acronym: PERTAIN

summary: This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.

ReferenceCitation: Rimawi M, Ferrero JM, de la Haba-Rodriguez J, Poole C, De Placido S, Osborne CK, Hegg R, Easton V, Wohlfarth C, Arpino G; PERTAIN Study Group. First-Line Trastuzumab Plus an Aromatase Inhibitor, With or Without Pertuzumab, in Human Epidermal Growth Factor Receptor 2-Positive and Hormone Receptor-Positive Metastatic or Locally Advanced Breast Cancer (PERTAIN): A Randomized, Open-Label Phase II Trial. J Clin Oncol. 2018 Oct 1;36(28):2826-2835. doi: 10.1200/JCO.2017.76.7863. Epub 2018 Aug 14.

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Centre Catherine de Sienne; Chimiotherapie

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: Casa di Cura MultiMedica Ospedale di Castellanza; UO Senologia Medica

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

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

location_facility: Ospedale Vito Fazzi; Div. Oncoematologia

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Clinique De La Sauvegarde; Chimiotherapie

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Baylor College of Medicine; Lester & Sue Smith Breast Ctr

location_facility: Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Hopital Morvan; Oncologie - Radiotherapie

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Hematology Oncology Associates; Carol G. Simon Ctr

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Ospedale S.S. Trinità Nuovo; Divisione Oncologia

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: University Hospital coventry; Oncology Department

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

location_facility: Jaslok Hospital & Research Centre; Medical Oncology

location_facility: IRCCS Fondazione Maugeri; Oncologia Medica I

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: A.O. Santa Maria Degli Angeli; U.O Di Oncologia Medica

location_facility: Washington University School of Medicine; Internal Medicine - Renal

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

title: A Randomized, Two-Arm, Open-Label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-Positive and Hormone Receptor-Positive Advanced (Metastatic or Locally Advanced) Breast Cancer

location_country:
Italy
India
United Kingdom
Brazil
United States
Spain
Turkey
France


type: EudraCT Number

title: A Phase 3b Randomized, Open-Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI + RTV) Plus Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients

summary: This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Arribas JR, Pialoux G, Gathe J, Di Perri G, Reynes J, Tebas P, Nguyen T, Ebrahimi R, White K, Piontkowsky D. Simplification to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir in adults with virologically suppressed HIV (STRATEGY-PI): 48 week results of a randomised, open-label, phase 3b, non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):581-9. doi: 10.1016/S1473-3099(14)70782-0. Epub 2014 Jun 5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Pozniak A, Markowitz M, Mills A, Stellbrink HJ, Antela A, Domingo P, Girard PM, Henry K, Nguyen T, Piontkowsky D, Garner W, White K, Guyer B. Switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of non-nucleoside reverse transcriptase inhibitor with emtricitabine and tenofovir in virologically suppressed adults with HIV (STRATEGY-NNRTI): 48 week results of a randomised, open-label, phase 3b non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):590-9. doi: 10.1016/S1473-3099(14)70796-0. Epub 2014 Jun 5.

ReferenceType: derived

ReferenceCitation: Arribas JR, DeJesus E, van Lunzen J, Zurawski C, Doroana M, Towner W, Lazzarin A, Nelson M, McColl D, Andreatta K, Swamy R, Szwarcberg J, Nguyen T. Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens: week 96 results of STRATEGY-PI. HIV Clin Trials. 2017 May;18(3):118-125. doi: 10.1080/15284336.2017.1330440. Epub 2017 May 30. Erratum In: HIV Clin Trials. 2018 Aug;19(4):163.

publisher_dissemination: Informa

ReferenceCitation: Gathe J, Arribas JR, Van Lunzen J, Garner W, Speck RM, Bender R, Shreay S, Nguyen T. Patient-Reported Symptoms over 48 Weeks in a Randomized, Open-Label, Phase 3b Non-inferiority Trial of Adults with HIV Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir DF Versus Continuation of Ritonavir-Boosted Protease Inhibitor with Emtricitabine and Tenofovir DF. Patient. 2015 Oct;8(5):445-54. doi: 10.1007/s40271-015-0137-9.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
Portugal
United Kingdom
Switzerland
Austria
Belgium
United States
Spain
Canada
Puerto Rico
France

location_facility: John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center

location_facility: Tarrant County Infectious Disease Associates

location_facility: University of Puerto Rico School of Medicine

location_facility: Archet 1 Chu Nice Department of Infectology

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Universitätsklinikum Essen, Dermatologie, HIV Ambulanz

location_facility: Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa

location_facility: Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie

location_facility: Clinic of Infectious Diseases, University of Milan-San Paolo Hospital

location_facility: Northwestern University Division of Infectious Diseases

location_facility: University of Torino, Dept of Infectious Disease

location_facility: Midway Immunology & Research Center, LLC

location_facility: National Institute for Infectious Diseases "L. Spallanzani"

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: La Playa Medical Group and Clinical Research

location_facility: Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.

location_facility: Infectious Diseases Department, Hospital Carlos III

location_facility: Southwest Infectious Disease Clinical Research, Inc

location_facility: Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68

location_facility: Infectious Diseases Associates of NW FL, P.A.

location_facility: Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen

location_facility: University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

acronym: OCTAVE

summary: This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.

study_start_date_type: Actual

design_allocation: Non-Randomized

ReferenceCitation: Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.

evidence: open (via crossref license)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

publisher_dissemination: Oxford University Press

ReferenceCitation: Hudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2023 Mar;16(2):95-103. doi: 10.1007/s40271-022-00603-w. Epub 2022 Nov 7.

ReferenceCitation: Biedermann L, Dubinsky MC, Vermeire S, Fellmann M, Gardiner S, Hur P, Mundayat R, Panes J, Rubin DT. Health-Related Quality of Life Outcomes With Tofacitinib Treatment in Patients With Ulcerative Colitis in the Open-Label Extension Study, OCTAVE Open. Inflamm Bowel Dis. 2023 Sep 1;29(9):1370-1379. doi: 10.1093/ibd/izac222.

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories:
LIRIAS (KU Leuven)
PubMed Central
www.zora.uzh.ch

repositories_concat: LIRIAS (KU Leuven);PubMed Central;www.zora.uzh.ch

repositories_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.

ReferenceCitation: Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061.

ReferenceCitation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

ReferenceCitation: Panes J, Vermeire S, Dubinsky MC, Loftus EV, Lawendy N, Wang W, Salese L, Su C, Modesto I, Guo X, Colombel JF. Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials. J Crohns Colitis. 2021 Nov 8;15(11):1852-1863. doi: 10.1093/ecco-jcc/jjab065.

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.

ReferenceCitation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan(R) Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.

ReferenceCitation: Colombel JF, Osterman MT, Thorpe AJ, Salese L, Nduaka CI, Zhang H, Lawendy N, Friedman GS, Quirk D, Su C, Reinisch W. Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):116-125.e5. doi: 10.1016/j.cgh.2020.10.004. Epub 2020 Oct 9.

ReferenceCitation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

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

repository_institution: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panes J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repositories_institution: Washington University School of Medicine - Digital Commons@Becker

ReferenceCitation: Sands BE, Armuzzi A, Marshall JK, Lindsay JO, Sandborn WJ, Danese S, Panes J, Bressler B, Colombel JF, Lawendy N, Maller E, Zhang H, Chan G, Salese L, Tsilkos K, Marren A, Su C. Efficacy and safety of tofacitinib dose de-escalation and dose escalation for patients with ulcerative colitis: results from OCTAVE Open. Aliment Pharmacol Ther. 2020 Jan;51(2):271-280. doi: 10.1111/apt.15555. Epub 2019 Oct 29.

ReferenceCitation: Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panes J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

repositories:
LIRIAS (KU Leuven)
PubMed Central
pdfs.semanticscholar.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;pdfs.semanticscholar.org

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:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Croatia
Czechia
Canada
Serbia
France
Colombia
Slovakia
Hungary
Denmark
United States
Latvia
Ukraine
Romania
Belgium
Estonia
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I

location_facility: Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology

location_facility: Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych

location_facility: The Gastroenterology Group of South Jersey

location_facility: Wisconsin Center for Advanced Research - a division of GI Associates, LLC

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'.

location_facility: Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: University of Alberta - Zeidler Ledcor Centre

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,

location_facility: Klinicke Centrum ISCARE I.V.F., Gastroenterologie

location_facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2

location_facility: Municipal Budget Institution of Healthcare of Novosibirsk

location_facility: "Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC ""Ukrainian

location_facility: North Florida Gastroenterology Research, LLC

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Hopital Saint Antoine - Service de Gastroenterologie

location_facility: Perlman Medical Offices - UC San Diego Health System

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2

location_facility: State Institution "L.T. Malaya Therapy Institute of NAMS of Ukraine"

location_facility: State budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Krankenhaus Barmherzige Brueder St. Veit/Glan

location_facility: CI of Uzhgorod Regional Rada Uzhgorod Central Regional Hospital". Therapy Department. SHEI Uzhgorod

location_facility: "KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra

location_facility: Federal State Budgetary Institution Scientific Research Institute of Physiology and Fundamental

location_facility: Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital'

location_facility: Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"

location_facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

location_facility: Limited Liability Company Medical Company "Hepatolog"

location_facility: Samara Diagnostic center, X-ray Department

location_facility: Poliklinika Libris, Synergy group, a.s.,

location_facility: McGovern Medical School -The University of Texas Health Science Center at Houston

location_facility: Clinical Centre of Serbia Clinic for Gastroenterology and Hepatology

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Hospital de Clinicas de Porto Alegre - HCPA

location_facility: VCU Health System Digestive Health Center

location_facility: Federal State Budgetary Institution "State Scientific Centre of Coloproctology n.a. A.N. Ryzhikh"

location_facility: SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases

location_facility: Huron Gastroenterology Associates - Center for Digestive Care

location_facility: The Edith Wolfson Medical Center/Gastroenterology Department

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

location_facility: The Hospital of Hyogo College of Medicine

location_facility: North Shore Hospital (Waitemata District Health Board)

location_facility: National Hospital Organization Mito Medical Center

location_facility: The North West London Hospitals NHS Trust

location_facility: Center for Endoscopy- Covenant Surgical Partners

location_facility: Altman Clinical and Translational Research Institute

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Hopital Beaujon, Gastroenterologie, MICI et Assistance Nutritive

location_facility: East Ann Arbor Health and Geriatrics Center -UMHS

location_facility: FSBI "Scientific Research Institute of Physiology and Fundamental Medicine"

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

location_facility: Nemocnice Strakonice, a.s., Interni oddeleni

location_facility: Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály

location_facility: Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.

location_facility: Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit

location_facility: Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital Kliniczny nr

location_facility: Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust

location_facility: Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department

location_facility: Montreal General Hospital - McGill University Health Care Centre

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Manninger Jeno Orszagos Traumatologiai Intezet

location_facility: Medical Science Research Building 1 - UMHS

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: Carolina Research, Carolina Digestive Diseases

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly

location_facility: Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital

location_facility: Cotton O'Neil Clinical Research Center, Digestive Health

location_facility: Chris Hani Baragwanath Academic Hospital

location_facility: Hôpital Saint Louis - Service d'hepato-gastroenterologie

location_facility: Shiga University of Medical Science Hospital

location_facility: State budget Healthcare Institution Moscow regional scientific research clinical institute

location_facility: AOU Mater Domini - U.O. Fisiopatologia Digestiva

location_facility: Universitatsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Baylor College of Medicine- Baylor Medical Center

location_facility: National Hospital Organization Sendai Medical Center

location_facility: University of Calgary, Heritage Medical Research Clinic, TRW Building

location_facility: University Medical Center Groningen (UMCG)

location_facility: Istituto Clinico Humanitas IRCCS-IBD Center

location_facility: Clinical Centre of Vojvodina Emergency Internal Medicine Division

location_facility: London Health Sciences Centre - University Hospital

location_facility: Clinical Centre of Kragujevac Clinic for Gastroenterology and Hepatology

location_facility: Kyiv Municipal Clinical Hospital #18, Proctology Department

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia

location_facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob

location_facility: Columbia University Irving Medical Center

location_facility: UCSF Center for Colitis and Crohn's Disease

location_facility: Minicipal Institution City Hospital #7, Therapeutic Department,

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital

location_facility: State budget institution of healthcare of Yaroslavl region Regional clinical hospital


title: Lux-Breast 3; Randomised Phase II Study of Afatinib Alone or in Combination With Vinorelbine Versus Investigator's Choice of Treatment in Patients With HER2 Positive Breast Cancer With Progressive Brain Metastases After Trastuzumab and/or Lapatinib Based Therapy

summary: The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

ReferenceCitation: Cortes J, Dieras V, Ro J, Barriere J, Bachelot T, Hurvitz S, Le Rhun E, Espie M, Kim SB, Schneeweiss A, Sohn JH, Nabholtz JM, Kellokumpu-Lehtinen PL, Taguchi J, Piacentini F, Ciruelos E, Bono P, Ould-Kaci M, Roux F, Joensuu H. Afatinib alone or afatinib plus vinorelbine versus investigator's choice of treatment for HER2-positive breast cancer with progressive brain metastases after trastuzumab, lapatinib, or both (LUX-Breast 3): a randomised, open-label, multicentre, phase 2 trial. Lancet Oncol. 2015 Dec;16(16):1700-10. doi: 10.1016/S1470-2045(15)00373-3. Epub 2015 Nov 17.

oa_host_type: repository

license: cc-by

license_normalized: cc-by

version: submittedVersion

unpaywall_oa_status: green

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Finland
Italy
United States
Korea, Republic of
Spain
Canada
France

location_facility: 1200.67.10108 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49006 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34005 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34006 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10106 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33008 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49007 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.11004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33005 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33009 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.35802 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49008 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.35801 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33010 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.39002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.39001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49005 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.35803 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.11002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.11003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33011 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33012 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10105 Boehringer Ingelheim Investigational Site


title: A Multicenter, Two Arm, Randomized, Open Label Clinical Study Investigating Renal Function in an Advagraf® Based Immunosuppressive Regimen With or Without Sirolimus in Kidney Transplant Patients

acronym: ADHERE

summary: The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.

primary_purpose: Prevention

ipd_sharing: Yes

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

location_country:
Germany
Belarus
Italy
Poland
Hungary
Hong Kong
Australia
Netherlands
Austria
Belgium
Korea, Republic of
Spain
Turkey
Taiwan
Czechia
Russian Federation
France


title: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

summary: This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).

ReferenceCitation: Celli B, Crater G, Kilbride S, Mehta R, Tabberer M, Kalberg CJ, Church A. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest. 2014 May;145(5):981-991. doi: 10.1378/chest.13-1579. Erratum In: Chest. 2022 Jul;162(1):269.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Slovakia
Hungary
Norway
Denmark
Japan
Sweden
Netherlands
Belgium
United States
Ukraine
Estonia
Philippines
France


title: A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

summary:
The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications.

Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.

location_country:
Germany
Italy
Portugal
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Canada
Puerto Rico
France

location_facility: University Health Network/Toronto General Hospital

location_facility: Division of Infectious Disease, Department of Medicine, University Hospital Freiburg

location_facility: IRCCS Ospedale San Raffaele Centro San Luigi, Unità Operativa di Malattie Infettive

location_facility: Department of Dermatology University Hospital Essen

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Southwest Infectious Disease Associates, Inc.

location_facility: Infectious Disease Specialists of America

location_facility: St. Joseph's Hospital d/b/a Comprehensive Research Institute

location_facility: Tarrant County Infectious Disease Associates

location_facility: Kaiser Permanente Medical Center, San Francisco

location_facility: McGill University Health Center, Montreal Chest Institute

location_facility: Department of Dermatology, Allergy, and Infectious Disease University Vienna Medical School

location_facility: Clinical and Translational Research Center - UNC Hospitals

location_facility: Universitätsklinikum Eppendorf Ambulanzzentrum des UKE GmbH, Infekiologie

location_facility: Private Practice Gute & Locher & Lutz, Infektiologikum

location_facility: Hopital Tenon Service des Maladies infectieuses et tropicales

location_facility: Division of HIV/AIDS, St. Paul's Hospital

location_facility: Living Hope Education and Research Consultants

location_facility: National Institute for Infectious Diseases "L. Spallanzani" IRCCS

location_facility: Clinical Research - Infectious Diseases Unit Alfred Hospital

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Cliniques Universitaires Saint-Luc - UCL

location_facility: Claudia T Martorell, MD., LLC dba The Research Institute

location_facility: HOSPITAL SAINT LOUIS - Services des Maladies Infectieuses

location_facility: Foundation "IRCCS Policlinico San Matteo Hospital"

location_facility: Serviço de Doenças Infecciosas, Hospital S. Joao

location_facility: North Shore University Hospital--Division of Infectious Diseases

location_facility: Medizinische Universitätsklinik I der Friedrich-Wilhelms Universität Bonn

location_facility: Jeffrey Goodman Special Care Clinic/Los Angeles Gay and Lesbian Center

location_facility: San Gerardo Hospital - Uo Malattie Infettive

location_facility: The Brody School of Medicine at East Carolina University

location_facility: Community Research Initiative of New England

location_facility: LKH Medical University Graz West, Department of Internal Medicine

location_facility: Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses

location_facility: Universitätsklinikum Innsbruck Universitätsklinik für Dermatologie und Venerologie

location_facility: Johns Hopkins Rockland Physicians Practice and Research Group at Greenspring Station

location_facility: La Playa Medical Group and Clinical Research

location_facility: I Div Infectious Diseases, Luigi Sacco Hospital

location_facility: Hospital Universitario de Elche, Unidad de Enfermedades Infecciosas

location_facility: Maple Leaf Research Maple Leaf Medical Clinic

location_facility: Hospital of the University of Pennsylvania

location_facility: Hopital Saint Antoine- Service Maladies infectieuses

location_facility: Clinical Research, Grahame Hayton Unit Ambrose King Centre, The Royal London Hospital


title: Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy

acronym: FIRSTANA

summary:
Primary Objective:

To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy.

Secondary Objectives:

To evaluate safety in the 3 treatment arms.

To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for:

Progression Free Survival (PFS) (RECIST 1.1)
Tumor progression free survival (RECIST 1.1)
Tumor response in participants with measurable disease (RECIST 1.1),
PSA response
PSA-Progression free survival (PSA-PFS).
Pain response in participants with stable pain at baseline
Pain progression free survival
Time to occurrence of any skeletal related events (SRE)
To compare Health-Related Quality of Life (HRQL).
To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

ReferenceCitation: Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: gold

ReferenceCitation: Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Mace S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28.

repository_institution: Radboud University - Radboud Repository

repositories_concat: PubMed Central;repository.ubn.ru.nl

repositories_institution:
PubMed Central - Europe PMC
Radboud University - Radboud Repository

ReferenceCitation: Oudard S, Fizazi K, Sengelov L, Daugaard G, Saad F, Hansen S, Hjalm-Eriksson M, Jassem J, Thiery-Vuillemin A, Caffo O, Castellano D, Mainwaring PN, Bernard J, Shen L, Chadjaa M, Sartor O. Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA. J Clin Oncol. 2017 Oct 1;35(28):3189-3197. doi: 10.1200/JCO.2016.72.1068. Epub 2017 Jul 28.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher_dissemination: Springer

ReferenceCitation: Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available.

lead_sponsor: Sanofi

location_country:
Finland
Germany
Poland
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Belarus
Portugal
Denmark
United States
Ukraine
Romania
China
Peru
Italy
Sweden
Mexico
Spain
Taiwan
Russian Federation
Israel

location_facility:
Investigational Site Number 076006
Investigational Site Number 276005
Investigational Site Number 840028
Investigational Site Number 840012
Investigational Site Number 484004
Investigational Site Number 250008
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Investigational Site Number 124006
Investigational Site Number 840003
Investigational Site Number 642003
Investigational Site Number 724001
Investigational Site Number 250009
Investigational Site Number 840038
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Investigational Site Number 203002
Investigational Site Number 156002
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Investigational Site Number 804001
Investigational Site Number 840018
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Investigational Site Number 392006
Investigational Site Number 208002
Investigational Site Number 840001
Investigational Site Number 840037
Investigational Site Number 840023
Investigational Site Number 484005
Investigational Site Number 840014
Investigational Site Number 724007
Investigational Site Number 156003
Investigational Site Number 076009
Investigational Site Number 036003
Investigational Site Number 124002
Investigational Site Number 124003
Investigational Site Number 752001
Investigational Site Number 484007
Investigational Site Number 642007
Investigational Site Number 840017
Investigational Site Number 804004
Investigational Site Number 616002
Investigational Site Number 724003
Investigational Site Number 840005
Investigational Site Number 840238
Investigational Site Number 642002
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Investigational Site Number 036016
Investigational Site Number 124004
Investigational Site Number 208004
Investigational Site Number 156005
Investigational Site Number 620001
Investigational Site Number 208003
Investigational Site Number 840026
Investigational Site Number 840009
Investigational Site Number 156004
Investigational Site Number 250004
Investigational Site Number 250010
Investigational Site Number 643008
Investigational Site Number 203004
Investigational Site Number 840030
Investigational Site Number 076004
Investigational Site Number 604006
Investigational Site Number 724006
Investigational Site Number 392005
Investigational Site Number 840032
Investigational Site Number 276002
Investigational Site Number 620004
Investigational Site Number 112004
Investigational Site Number 246003
Investigational Site Number 036009
Investigational Site Number 620002
Investigational Site Number 484009
Investigational Site Number 484003
Investigational Site Number 642005
Investigational Site Number 250005
Investigational Site Number 620005
Investigational Site Number 642004
Investigational Site Number 376002
Investigational Site Number 792001
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Investigational Site Number 376003
Investigational Site Number 616005
Investigational Site Number 604005
Investigational Site Number 276001
Investigational Site Number 124005
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Investigational Site Number 752003
Investigational Site Number 752002
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Investigational Site Number 036001
Investigational Site Number 484008
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Investigational Site Number 380005
Investigational Site Number 246002
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Investigational Site Number 158003
Investigational Site Number 076001
Investigational Site Number 604001
Investigational Site Number 076005
Investigational Site Number 804006
Investigational Site Number 840015


type: Registry Identifier

title: A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma

summary: This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.

status: Withdrawn

study_completion_date_type: Anticipated

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Poland
Singapore
Japan
Brazil
United States
Spain
Turkey
Canada
Russian Federation
France

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Oklahoma Health Sciences Center

status_simplified: Unknown


title: A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor

summary: This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). The anticipated time on study treatment is 24 weeks.

status: Terminated

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Finland
Italy
Denmark
Sweden
Netherlands
United States
Spain
Greece
Puerto Rico
Russian Federation
France


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS US 196 0140

summary: This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).

location_country:
Germany
Poland
United Kingdom
Netherlands
Austria
Belgium
United States
France

location_facility: Columbia Medical Group, The Frist Clinic

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: Emory University, Infectious Disease Clinic

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny

location_facility: Erasmus University Medical Center Rotterdam

location_facility: Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi

location_facility: Scientific Clinical Research, Inc c/o Segal Institute for Clinical Research

location_facility: Digestive Health Specialists of the Southeast

location_facility: Virginia Mason Medical Center, Digestive Disease Institute

location_facility: Cornell University Gastroenterology & Hepatology

location_facility: Radaboud University Nijmegen Medical Centre (UMC St Radboud)

location_facility: Hôpital de I´Archet 2, Service Hépatologie

location_facility: Infectious Disease Specialists of Atlanta

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Centre Hospitalier Régional d'Orléans, Hôpital de la Source

location_facility: Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: Centre Hospitalier Universitaire Sart Tilman Liège

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny

location_facility: South Florida Center of Gastroenterology, LLC

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: Centre Hospitalier Universitaire de Strasbourg - Hôpital Civil

location_facility: Liver Institute of Virginia, Bon Secours

location_facility: Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny

location_facility: Academisch Medisch Centrum Universiteit Van Amsterdam

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Pol-SaNa-Med" Sp. z o.o.

location_facility: University Hospitals Case Medical Center

location_facility: San Francisco Veterans Affairs Medical Center

location_facility: Henry Ford Health System-Columbus center

location_facility: Nottingham University Hospitals NHS Trust


title: A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.

ReferenceCitation: Esquenazi A, Brashear A, Deltombe T, Rudzinska-Bar M, Krawczyk M, Skoromets A, O'Dell MW, Grandoulier AS, Vilain C, Picaut P, Gracies JM. The Effect of Repeated abobotulinumtoxinA (Dysport(R)) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury. PM R. 2021 May;13(5):488-495. doi: 10.1002/pmrj.12459. Epub 2020 Sep 11.

publisher_dissemination: Wiley

ReferenceCitation: Esquenazi A, Stoquart G, Hedera P, Jacinto LJ, Dimanico U, Constant-Boyer F, Brashear A, Grandoulier AS, Vilain C, Picaut P, Gracies JM. Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2020 Sep;12(9):853-860. doi: 10.1002/pmrj.12348. Epub 2020 Mar 27.

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Gracies JM, Esquenazi A, Brashear A, Banach M, Kocer S, Jech R, Khatkova S, Benetin J, Vecchio M, McAllister P, Ilkowski J, Ochudlo S, Catus F, Grandoulier AS, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Lower Limb Spasticity Study Group. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology. 2017 Nov 28;89(22):2245-2253. doi: 10.1212/WNL.0000000000004687. Epub 2017 Nov 1.

repository_institution: Academy of Humanities and Economics in Lodz - Homo Politicus

repositories_concat: PubMed Central;ruj.uj.edu.pl

publisher_dissemination: Wolters Kluwer Health

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, annotated 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 study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country:
Italy
Poland
Portugal
Slovakia
Hungary
Australia
Belgium
United States
Czechia
Russian Federation
France

location_facility: University of North Texas HSC at Ben Hogan Center

location_facility: Hôpital Sébastopol, Médecine Physique et Réadaptation, CHU Reims

location_facility: Wake Forest University Baptist Medical Center

location_facility: Neurologicka klinika, Univerzitna nemocnica Bratislava

location_facility: State Institution "Scientific Centre of Neurology of Russian Academy of Medical Sciences"

location_facility: University of North Carolina - Chapel Hill

location_facility: National Institute for Medical Rehabilitation

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

location_facility: Servizio di Neurofisiologia Clinica-Ospedale San Raffaele

location_facility: Université catholique de Louvain av Hippocrate 10

location_facility: Associated Neurologists of Southern CT, PC

location_facility: The University of Texas Southwestern Medical Center at Dallas

location_facility: Polo IRCCS Eugenio Medea La Nostra Famiglia

location_facility: Service de Réeducation Fonctionnelle, CHU de Brest, Hôpital Morvan


title: Efficacy and Safety of HIV Vaccine 732462 in ART-naïve HIV-1 Infected Persons

summary: This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the initiation of treatment.

location_country:
United States
Spain
Germany
France


acronym: BLAST

lead_sponsor: Amgen Research (Munich) GmbH

summary: The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.

ReferenceCitation: Gokbuget N, Zugmaier G, Dombret H, Stein A, Bonifacio M, Graux C, Faul C, Bruggemann M, Taylor K, Mergen N, Reichle A, Horst HA, Havelange V, Topp MS, Bargou RC. Curative outcomes following blinatumomab in adults with minimal residual disease B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2020 Nov;61(11):2665-2673. doi: 10.1080/10428194.2020.1780583. Epub 2020 Jul 3.

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

ReferenceCitation: Jen EY, Xu Q, Schetter A, Przepiorka D, Shen YL, Roscoe D, Sridhara R, Deisseroth A, Philip R, Farrell AT, Pazdur R. FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease. Clin Cancer Res. 2019 Jan 15;25(2):473-477. doi: 10.1158/1078-0432.CCR-18-2337. Epub 2018 Sep 25.

oa_colors: green other

evidence: open (via free pdf)

evidence: oa repository (via page says license)

unpaywall_oa_status: bronze

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Gokbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Bruggemann M, Horst HA, Havelange V, Stieglmaier J, Wessels H, Haddad V, Benjamin JE, Zugmaier G, Nagorsen D, Bargou RC. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22. Erratum In: Blood. 2019 Jun 13;133(24):2625.

evidence: open (via free article)

ReferenceCitation: Zhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE((R))) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4.

location_facility: 1406 - Hospital Universitari i Politècnic La Fe de Valencia

location_facility: 1407 - Unidad de Citogenética Oncológica

location_facility: 1202 - CHU de Bordeaux - Hôpital Haut Lévêque

location_facility: 1303 - Istituto di Ematologia "L.& A.Seràgnoli" Azienda

location_facility: 1314 - Azienda Ospedaliera Spedali Civili Brescia

location_facility: 1312 - Azienda Ospedaliera Universitaria San Martino

location_facility: 1405 - Hospital Universitari Son Espases

location_facility: 2001 - Russian Hematology Research Center

location_facility: 1502 - Cliniques Universitaires de Saint-Luc

location_facility: 1022 - Universitätsklinkum Carl Gustav Carus Dresden

location_facility: 1213 - Centre Hospitalier Universitaire de Nice

location_facility: 1003 - Universitätsklinikum Schleswig-Holstein

location_facility: 1501 - Cliniques Universitaires UCL de Mont Godinne

location_facility: 1315 - Azienda Ospedaliero-Universitaria S. Giovanni Battista (Le Molinette)

location_facility: 1010 - Klinikum der Universität München - Großhadern

location_facility: 1607 - Nottingham City Hospital NHS Trust

location_facility: 2102 - Spitalul Clinic Coltea, Hematologie

location_facility: 2106 - Institutul Oncologic "Prof. Dr. I. Chiricuta"

location_facility: 1309 - Azienda Ospedaliera Antonio Cardarelli

location_facility: 1905 - Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: 2101 - Institutul Clinic Fundeni, Hematologie II

location_facility: 1310 - Fondazione Policlinico Tor Vergata

location_facility: 1901 - Klinika Hematologii - Instytut Hematologii i Transfuzjologii

location_facility: 1401 - ICO Hospital Germans Trias I Pujol

location_facility: 1404 - Hospital Clínic Servei d´Hematologia

location_facility: 1001 - Julius-Maximilians-Universität Würzburg

location_facility: 1308 - Ospedali Riuniti "Villa Sofia-Cervello"

location_facility: 1402 - Complexo Hospitalario Universitario A Coruña

title: A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (BLAST)

location_country:
Germany
Italy
Poland
United Kingdom
Romania
Netherlands
Austria
Belgium
Spain
Russian Federation
France


title: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

summary: The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

ReferenceCitation: Vieta E, Thase ME, Naber D, D'Souza B, Rancans E, Lepola U, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant. Eur Neuropsychopharmacol. 2014 Apr;24(4):564-74. doi: 10.1016/j.euroneuro.2013.12.008. Epub 2013 Dec 21.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Targacept Inc.

location_country:
Finland
Germany
Lithuania
Poland
Hungary
Sweden
Latvia
Estonia
Czech Republic
France


acronym: RAINBOW

lead_sponsor: Eli Lilly and Company

summary: This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.

ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Yamaguchi K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Omuro Y, Tamura T, Piao Y, Homma G, Jen MH, Liepa AM, Muro K. Quality of Life Associated with Ramucirumab Treatment in Patients with Advanced Gastric Cancer in Japan: Exploratory Analysis from the Phase III RAINBOW Trial. Clin Drug Investig. 2021 Jan;41(1):53-64. doi: 10.1007/s40261-020-00979-3. Epub 2020 Dec 23.

ReferenceCitation: Cascinu S, Bodoky G, Muro K, Van Cutsem E, Oh SC, Folprecht G, Ananda S, Girotto G, Wainberg ZA, Miron MLL, Ajani J, Wei R, Liepa AM, Carlesi R, Emig M, Ohtsu A. Tumor Response and Symptom Palliation from RAINBOW, a Phase III Trial of Ramucirumab Plus Paclitaxel in Previously Treated Advanced Gastric Cancer. Oncologist. 2021 Mar;26(3):e414-e424. doi: 10.1002/onco.13623. Epub 2020 Dec 23.

repository_institution: University of California - eScholarship University of California

repositories_concat: LIRIAS (KU Leuven);PubMed Central;University of Melbourne - Minerva Access;escholarship.org;www.repositoriosalud.es

ReferenceCitation: De Vita F, Borg C, Farina G, Geva R, Carton I, Cuku H, Wei R, Muro K. Ramucirumab and paclitaxel in patients with gastric cancer and prior trastuzumab: subgroup analysis from RAINBOW study. Future Oncol. 2019 Aug;15(23):2723-2731. doi: 10.2217/fon-2019-0243. Epub 2019 Jun 25. Erratum In: Future Oncol. 2021 Sep;17(25):3409.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Chau I, Fuchs CS, Ohtsu A, Barzi A, Liepa AM, Cui ZL, Hsu Y, Al-Batran SE. Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials. Eur J Cancer. 2019 Jan;107:115-123. doi: 10.1016/j.ejca.2018.11.013. Epub 2018 Dec 14.

oa_host_type: publisher

ReferenceCitation: Tabernero J, Ohtsu A, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Ajani JA, Tomasek J, Safran H, Chandrawansa K, Hsu Y, Heathman M, Khan A, Ni L, Melemed AS, Gao L, Ferry D, Fuchs CS. Exposure-Response Analyses of Ramucirumab from Two Randomized, Phase III Trials of Second-line Treatment for Advanced Gastric or Gastroesophageal Junction Cancer. Mol Cancer Ther. 2017 Oct;16(10):2215-2222. doi: 10.1158/1535-7163.MCT-16-0895. Epub 2017 Jul 17.

repository_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Al-Batran SE, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov ON, Kim TY, Cunningham D, Rougier P, Muro K, Liepa AM, Chandrawansa K, Emig M, Ohtsu A, Wilke H. Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. Ann Oncol. 2016 Apr;27(4):673-9. doi: 10.1093/annonc/mdv625. Epub 2016 Jan 7.

ReferenceCitation: Shitara K, Muro K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Yamaguchi K, Segawa Y, Omuro Y, Tamura T, Doi T, Yukisawa S, Yasui H, Nagashima F, Gotoh M, Esaki T, Emig M, Chandrawansa K, Liepa AM, Wilke H, Ichimiya Y, Ohtsu A. Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer. Gastric Cancer. 2016 Jul;19(3):927-38. doi: 10.1007/s10120-015-0559-z. Epub 2015 Oct 28.

ReferenceCitation: Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.

title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Chile
France
Lithuania
Portugal
Hungary
United States
Romania
Belgium
Estonia
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


acronym: ARTEMIS Load

summary:
Primary Objective:

- Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone.

Secondary Objective:

Evaluate the rate of AF recurrences two months after randomization.
Assess the safety of the change from amiodarone to dronedarone
Assess dronedarone safety
Explore dronedarone and its active metabolite plasma level (in a subset of countries)
Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone (in a subset of countries)

ReferenceCitation: Naccarelli GV, Bhatt DL, Camm AJ, Le Heuzey JY, Lombardi F, Tamargo J, Martinez JM, Naditch-Brule L; ARTEMIS AF Investigators. Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies. J Cardiovasc Pharmacol Ther. 2020 Sep;25(5):425-437. doi: 10.1177/1074248420926874. Epub 2020 Jun 5.

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

repository_institution: St George's University of London - St George's Online Research Archive

version: acceptedVersion

publisher_dissemination: SAGE Publications

location_facility:
Investigational Site Number 410004
Investigational Site Number 484004
Investigational Site Number 012
Investigational Site Number 006
Investigational Site Number 158005
Investigational Site Number 410006
Investigational Site Number 756002
Investigational Site Number 004
Investigational Site Number 007
Investigational Site Number 250-003
Investigational Site Number 724004
Investigational Site Number 528005
Investigational Site Number 276-006
Investigational Site Number 724008
Investigational Site Number 158002
Investigational Site Number 250-006
Investigational Site Number 246-001
Investigational Site Number 380-009
Investigational Site Number 250-005
Investigational Site Number 724001
Investigational Site Number 380-007
Investigational Site Number 380-011
Investigational Site Number 484012
Investigational Site Number 250-007
Investigational Site Number 484016
Investigational Site Number 040-007
Investigational Site Number 003
Investigational Site Number 724005
Investigational Site Number 276-002
Investigational Site Number 158001
Investigational Site Number 040-002
Investigational Site Number 040-003
Investigational Site Number 002
Investigational Site Number 276-010
Investigational Site Number 756001
Investigational Site Number 380-005
Investigational Site Number 040-001
Investigational Site Number 484017
Investigational Site Number 013
Investigational Site Number 484005
Investigational Site Number 724007
Investigational Site Number 380-001
Investigational Site Number 484001
Investigational Site Number 250-008
Investigational Site Number 250-004
Investigational Site Number 826-007
Investigational Site Number 410002
Investigational Site Number 410003
Investigational Site Number 276-004
Investigational Site Number 410005
Investigational Site Number 246-004
Investigational Site Number 011
Investigational Site Number 158007
Investigational Site Number 724003
Investigational Site Number 380-004
Investigational Site Number 246-002
Investigational Site Number 724010
Investigational Site Number 276-001
Investigational Site Number 620001
Investigational Site Number 009
Investigational Site Number 040-005
Investigational Site Number 276-009
Investigational Site Number 376001
Investigational Site Number 380-002
Investigational Site Number 484013
Investigational Site Number 724006
Investigational Site Number 276-003
Investigational Site Number 040-004
Investigational Site Number 484009
Investigational Site Number 484003
Investigational Site Number 620005
Investigational Site Number 376002
Investigational Site Number 528004
Investigational Site Number 250-010
Investigational Site Number 528001
Investigational Site Number 040-006
Investigational Site Number 826-005
Investigational Site Number 484008
Investigational Site Number 233001
Investigational Site Number 158004
Investigational Site Number 484002
Investigational Site Number 001
Investigational Site Number 380-006
Investigational Site Number 724002
Investigational Site Number 010
Investigational Site Number 158008
Investigational Site Number 250-001
Investigational Site Number 246-003
Investigational Site Number 276-011
Investigational Site Number 276-005
Investigational Site Number 380-003
Investigational Site Number 250-009
Investigational Site Number 250-002
Investigational Site Number 826-002
Investigational Site Number 826006
Investigational Site Number 380-012
Investigational Site Number 528002
Investigational Site Number 826-001
Investigational Site Number 528003
Investigational Site Number 008
Investigational Site Number 724009
Investigational Site Number 276-007
Investigational Site Number 158006
Investigational Site Number 276-008
Investigational Site Number 484011
Investigational Site Number 158009
Investigational Site Number 158003
Investigational Site Number 005
Investigational Site Number 484015
Investigational Site Number 380-010
Investigational Site Number 410001

title: A Randomized, International, Multi-center, Open-label Study to Document Optimal Timing of Initiation of Dronedarone Treatment After Conversion With Loading Dose of Amiodarone in Patients With Persistent Atrial Fibrillation Requiring Conversion of AF.

source: euctr

location_country:
Finland
Germany
Italy
Portugal
Israel
United Kingdom
Australia
Netherlands
Austria
Mexico
Switzerland
Korea, Republic of
Spain
Taiwan
Estonia
France


acronym: PAOLA

summary: This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.

ReferenceCitation: Colao A, Bronstein MD, Brue T, De Marinis L, Fleseriu M, Guitelman M, Raverot G, Shimon I, Fleck J, Gupta P, Pedroncelli AM, Gadelha MR. Pasireotide for acromegaly: long-term outcomes from an extension to the Phase III PAOLA study. Eur J Endocrinol. 2020 Jun;182(6):583. doi: 10.1530/EJE-19-0762.

ReferenceCitation: Gadelha MR, Bronstein MD, Brue T, Coculescu M, Fleseriu M, Guitelman M, Pronin V, Raverot G, Shimon I, Lievre KK, Fleck J, Aout M, Pedroncelli AM, Colao A; Pasireotide C2402 Study Group. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Nov;2(11):875-84. doi: 10.1016/S2213-8587(14)70169-X. Epub 2014 Sep 24.

location_facility: University of Texas Southwestern Medical Center Division of Hematology/Oncolog

location_facility: Swedish Neuroscience Institute 550 17th Avenue, Suite 500

title: A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly

location_country:
Germany
Italy
Poland
Colombia
Israel
Argentina
Norway
Romania
Brazil
United Kingdom
Belgium
United States
Saudi Arabia
Spain
Turkey
Canada
Russian Federation
France

ipd_sharing: Undecided


title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes

acronym: SAVOR- TIMI 53

summary: The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

ReferenceCitation: Cavallari I, Bhatt DL, Steg PG, Leiter LA, McGuire DK, Mosenzon O, Im K, Raz I, Braunwald E, Scirica BM. Causes and Risk Factors for Death in Diabetes: A Competing-Risk Analysis From the SAVOR-TIMI 53 Trial. J Am Coll Cardiol. 2021 Apr 13;77(14):1837-1840. doi: 10.1016/j.jacc.2021.02.030. No abstract available.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Berg DD, Wiviott SD, Scirica BM, Gurmu Y, Mosenzon O, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Johanson P, Johansson PA, Langkilde AM, Raz I, Braunwald E, Sabatine MS. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577. doi: 10.1161/CIRCULATIONAHA.119.042685. Epub 2019 Aug 31.

ReferenceCitation: Bergmark BA, Bhatt DL, McGuire DK, Cahn A, Mosenzon O, Steg PG, Im K, Kanevsky E, Gurmu Y, Raz I, Braunwald E, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial. Circulation. 2019 Sep 17;140(12):1004-1014. doi: 10.1161/CIRCULATIONAHA.119.040144. Epub 2019 Jul 31.

ReferenceCitation: Scirica BM, Mosenzon O, Bhatt DL, Udell JA, Steg PG, McGuire DK, Im K, Kanevsky E, Stahre C, Sjostrand M, Raz I, Braunwald E. Cardiovascular Outcomes According to Urinary Albumin and Kidney Disease in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From the SAVOR-TIMI 53 Trial. JAMA Cardiol. 2018 Feb 1;3(2):155-163. doi: 10.1001/jamacardio.2017.4228.

publisher_dissemination: American Medical Association

ReferenceCitation: Xia C, Goud A, D'Souza J, Dahagam C, Rao X, Rajagopalan S, Zhong J. DPP4 inhibitors and cardiovascular outcomes: safety on heart failure. Heart Fail Rev. 2017 May;22(3):299-304. doi: 10.1007/s10741-017-9617-4.

ReferenceCitation: Mosenzon O, Leibowitz G, Bhatt DL, Cahn A, Hirshberg B, Wei C, Im K, Rozenberg A, Yanuv I, Stahre C, Ray KK, Iqbal N, Braunwald E, Scirica BM, Raz I. Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2017 Jan;40(1):69-76. doi: 10.2337/dc16-0621. Epub 2016 Oct 17.

repository_institution: Imperial College London - Spiral

publisher_dissemination: American Diabetes Association

ReferenceCitation: Scirica BM, Bhatt DL, Braunwald E, Raz I, Cavender MA, Im K, Mosenzon O, Udell JA, Hirshberg B, Pollack PS, Steg PG, Jarolim P, Morrow DA. Prognostic Implications of Biomarker Assessments in Patients With Type 2 Diabetes at High Cardiovascular Risk: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):989-998. doi: 10.1001/jamacardio.2016.3030.

ReferenceCitation: Cavender MA, Scirica BM, Raz I, Steg PG, McGuire DK, Leiter LA, Hirshberg B, Davidson J, Cahn A, Mosenzon O, Im K, Braunwald E, Bhatt DL. Cardiovascular Outcomes of Patients in SAVOR-TIMI 53 by Baseline Hemoglobin A1c. Am J Med. 2016 Mar;129(3):340.e1-8. doi: 10.1016/j.amjmed.2015.09.022. Epub 2015 Oct 31.

ReferenceCitation: Mosenzon O, Wei C, Davidson J, Scirica BM, Yanuv I, Rozenberg A, Hirshberg B, Cahn A, Stahre C, Strojek K, Bhatt DL, Raz I. Incidence of Fractures in Patients With Type 2 Diabetes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Nov;38(11):2142-50. doi: 10.2337/dc15-1068. Epub 2015 Sep 10.

ReferenceCitation: Leiter LA, Teoh H, Braunwald E, Mosenzon O, Cahn A, Kumar KM, Smahelova A, Hirshberg B, Stahre C, Frederich R, Bonnici F, Scirica BM, Bhatt DL, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial. Diabetes Care. 2015 Jun;38(6):1145-53. doi: 10.2337/dc14-2868. Epub 2015 Mar 10.

ReferenceCitation: Udell JA, Bhatt DL, Braunwald E, Cavender MA, Mosenzon O, Steg PG, Davidson JA, Nicolau JC, Corbalan R, Hirshberg B, Frederich R, Im K, Umez-Eronini AA, He P, McGuire DK, Leiter LA, Raz I, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Apr;38(4):696-705. doi: 10.2337/dc14-1850. Epub 2014 Dec 31.

ReferenceCitation: Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, Udell JA, Mosenzon O, Im K, Umez-Eronini AA, Pollack PS, Hirshberg B, Frederich R, Lewis BS, McGuire DK, Davidson J, Steg PG, Bhatt DL; SAVOR-TIMI 53 Steering Committee and Investigators*. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014 Oct 28;130(18):1579-88. doi: 10.1161/CIRCULATIONAHA.114.010389. Epub 2014 Sep 4. Erratum In: Circulation. 2015 Oct 13;132(15):e198.

ReferenceCitation: Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-26. doi: 10.1056/NEJMoa1307684. Epub 2013 Sep 2.

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

repository_institution: Conselleria de Salut i Consum del Govern de les Illes Balears - Docusalut

ReferenceCitation: Mosenzon O, Raz I, Scirica BM, Hirshberg B, Stahre CI, Steg PG, Davidson J, Ohman P, Price DL, Frederich B, Udell JA, Braunwald E, Bhatt DL. Baseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trial. Diabetes Metab Res Rev. 2013 Jul;29(5):417-26. doi: 10.1002/dmrr.2413. Epub 2013 May 21.

ReferenceCitation: Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Price DL, Chen R, Udell J, Raz I. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011 Nov;162(5):818-825.e6. doi: 10.1016/j.ahj.2011.08.006.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
Chile
Canada
France
Czech Republic
Hungary
Hong Kong
United States
India
China
Peru
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Mexico
Spain
South Africa
Taiwan
Russian Federation
Israel


acronym: CORRECT

lead_sponsor: Bayer

summary: This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC

ReferenceCitation: Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.

ReferenceCitation: Mross K, Frost A, Steinbild S, Hedbom S, Buchert M, Fasol U, Unger C, Kratzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. doi: 10.1158/1078-0432.CCR-11-1900. Epub 2012 Mar 15.

ReferenceCitation: Tabernero J, Lenz HJ, Siena S, Sobrero A, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Yoshino T, Goldberg RM, Sargent DJ, Wagner A, Laurent D, Teufel M, Jeffers M, Grothey A, Van Cutsem E. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol. 2015 Aug;16(8):937-48. doi: 10.1016/S1470-2045(15)00138-2. Epub 2015 Jul 13.

repositories_concat: PubMed Central;air.unimi.it

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

title: A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

location_country:
Germany
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Czech Republic
Portugal
Hungary
Switzerland
United States
Belgium
China
Italy
Netherlands
Spain
Israel


title: Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462

summary:
The purpose of this long-term follow-up study is to assess the long-term health status of HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the investigational HIV vaccine 732462. This study will provide additional data concerning the long-term benefits/risks associated with vaccination.

No vaccine will be administered during the study period. Vaccines were administered during the primary studies.

primary_purpose: Other

ReferenceCitation: Harrer T, Dinges W, Roman F; TH-HIV-011 study group. Long-term follow-up of HIV-1-infected adults who received the F4/AS01B HIV-1 vaccine candidate in two randomised controlled trials. Vaccine. 2018 May 3;36(19):2683-2686. doi: 10.1016/j.vaccine.2018.03.043. Epub 2018 Mar 30.

intervention_type: Procedure


title: Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

acronym: ECLIPSE

summary:
To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

location_country:
Germany
Italy
Poland
Hungary
Israel
Romania
United Kingdom
Netherlands
Belgium
United States
Spain
Luxembourg
Canada
France

location_facility:
Investigational Site Number 840350
Investigational Site Number 840348
Investigational Site Number 840346
Investigational Site Number 840217
Investigational Site Number 840308
Investigational Site Number 840201
Investigational Site Number 840207
Investigational Site Number 840310
Investigational Site Number 250008
Investigational Site Number 276003
Investigational Site Number 840326
Investigational Site Number 840202
Investigational Site Number 724004
Investigational Site Number 528005
Investigational Site Number 276006
Investigational Site Number 380003
Investigational Site Number 840330
Investigational Site Number 724008
Investigational Site Number 840220
Investigational Site Number 124006
Investigational Site Number 376005
Investigational Site Number 724001
Investigational Site Number 250009
Investigational Site Number 840327
Investigational Site Number 124007
Investigational Site Number 642006
Investigational Site Number 840205
Investigational Site Number 840320
Investigational Site Number 840336
Investigational Site Number 840101
Investigational Site Number 724005
Investigational Site Number 840338
Investigational Site Number 528006
Investigational Site Number 056003
Investigational Site Number 380007
Investigational Site Number 348005
Investigational Site Number 348001
Investigational Site Number 250007
Investigational Site Number 840302
Investigational Site Number 840307
Investigational Site Number 250002
Investigational Site Number 348003
Investigational Site Number 056004
Investigational Site Number 276010
Investigational Site Number 616008
Investigational Site Number 724007
Investigational Site Number 380008
Investigational Site Number 840312
Investigational Site Number 840345
Investigational Site Number 840219
Investigational Site Number 616006
Investigational Site Number 276008
Investigational Site Number 124003
Investigational Site Number 840323
Investigational Site Number 840215
Investigational Site Number 616002
Investigational Site Number 724003
Investigational Site Number 840213
Investigational Site Number 380006
Investigational Site Number 840329
Investigational Site Number 642002
Investigational Site Number 840341
Investigational Site Number 642001
Investigational Site Number 724010
Investigational Site Number 840339
Investigational Site Number 840103
Investigational Site Number 124004
Investigational Site Number 840106
Investigational Site Number 616007
Investigational Site Number 250004
Investigational Site Number 250010
Investigational Site Number 376001
Investigational Site Number 724006
Investigational Site Number 840208
Investigational Site Number 840211
Investigational Site Number 276002
Investigational Site Number 840105
Investigational Site Number 840353
Investigational Site Number 642005
Investigational Site Number 250005
Investigational Site Number 348004
Investigational Site Number 642004
Investigational Site Number 840317
Investigational Site Number 376002
Investigational Site Number 528004
Investigational Site Number 840331
Investigational Site Number 276007
Investigational Site Number 376003
Investigational Site Number 616005
Investigational Site Number 840309
Investigational Site Number 840343
Investigational Site Number 840335
Investigational Site Number 528001
Investigational Site Number 840344
Investigational Site Number 276001
Investigational Site Number 124005
Investigational Site Number 840303
Investigational Site Number 276004
Investigational Site Number 840311
Investigational Site Number 840337
Investigational Site Number 840321
Investigational Site Number 840351
Investigational Site Number 250003
Investigational Site Number 840314
Investigational Site Number 840347
Investigational Site Number 840212
Investigational Site Number 840316
Investigational Site Number 826005
Investigational Site Number 276009
Investigational Site Number 840305
Investigational Site Number 826001
Investigational Site Number 840216
Investigational Site Number 724002
Investigational Site Number 840315
Investigational Site Number 840322
Investigational Site Number 840301
Investigational Site Number 840218
Investigational Site Number 840102
Investigational Site Number 616004
Investigational Site Number 840352
Investigational Site Number 840104
Investigational Site Number 250006
Investigational Site Number 442001
Investigational Site Number 840319
Investigational Site Number 616001
Investigational Site Number 840318
Investigational Site Number 276012
Investigational Site Number 840203
Investigational Site Number 250001
Investigational Site Number 124001
Investigational Site Number 380001
Investigational Site Number 840313
Investigational Site Number 826006
Investigational Site Number 826002
Investigational Site Number 528003
Investigational Site Number 840204
Investigational Site Number 724009
Investigational Site Number 840328
Investigational Site Number 840306
Investigational Site Number 380002
Investigational Site Number 840210
Investigational Site Number 056001


lead_sponsor: Pierre Fabre Dermatology

summary: There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.

ReferenceType: background

ReferenceCitation: Leaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819. No abstract available.

ReferenceCitation: Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taieb A, Leaute-Labreze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.

ReferenceCitation: Leaute-Labreze C, Hoeger P, Mazereeuw-Hautier J, Guibaud L, Baselga E, Posiunas G, Phillips RJ, Caceres H, Lopez Gutierrez JC, Ballona R, Friedlander SF, Powell J, Perek D, Metz B, Barbarot S, Maruani A, Szalai ZZ, Krol A, Boccara O, Foelster-Holst R, Febrer Bosch MI, Su J, Buckova H, Torrelo A, Cambazard F, Grantzow R, Wargon O, Wyrzykowski D, Roessler J, Bernabeu-Wittel J, Valencia AM, Przewratil P, Glick S, Pope E, Birchall N, Benjamin L, Mancini AJ, Vabres P, Souteyrand P, Frieden IJ, Berul CI, Mehta CR, Prey S, Boralevi F, Morgan CC, Heritier S, Delarue A, Voisard JJ. A randomized, controlled trial of oral propranolol in infantile hemangioma. N Engl J Med. 2015 Feb 19;372(8):735-46. doi: 10.1056/NEJMoa1404710.

publisher_dissemination: Massachusetts Medical Society

location_facility: Spitalul Clinic Urgenta pentru Copii Grigore Alexandrescu

location_facility: Spitalul Clinic de Urgenta pentu Copii Sf. Maria

location_facility: Spitalul de Urgenta Copii, Louis Turcanu

location_facility: Hopital Robert Debre - Consultation de Dermatologie

location_facility: Eastern Clinical Research Unit - Box Hill Hospital

location_facility: Servicio de Dermatologia del Hospital Infantil

location_facility: Hospital Universitario Infantil Niño Jesús

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Klinika Chirurgii i Urologii Dzieci i Mlodziezy Akademii Medycznej

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Klinika Onkologii, Centrum Zdrowia Dziecka

location_facility: Department of Pediatric Surgery and Oncology

location_facility: Medical University - Filatov Pediatric Hospital

title: A Randomised, Controlled, Multidose, Multicentre, Adaptive Phase II/III Study in Infants With Proliferating Infantile Hemangiomas (IHs) Requiring Systemic Therapy to Compare 4 Regimens of Propranolol (1 or 3 mg/kg/Day for 3 or 6 Months) to Placebo (Double Blind).

location_country:
Germany
Italy
Lithuania
Poland
New Zealand
Hungary
Romania
Australia
Mexico
United States
Spain
Peru
Canada
Czech Republic
Russian Federation
France