title: A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection

summary: The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

ReferenceCitation: Jensen DM, Asselah T, Dieterich D, Foster GR, Sulkowski MS, Zeuzem S, Mantry P, Yoshida EM, Moreno C, Ouzan D, Wright M, Morano LE, Buynak R, Bourlière M, Hassanein T, Nishiguchi S, Kao JH, Omata M, Paik SW, Wong DK, Tam E, Kaita K, Feinman SV, Stern JO, Scherer J, Quinson AM, Voss F, Gallivan JP, Böcher WO, Ferenci P. Faldaprevir, pegylated interferon, and ribavirin for treatment-naïve HCV genotype-1: pooled analysis of two phase 3 trials. Ann Hepatol. 2016 May-Jun;15(3):333-49. doi: 10.5604/16652681.1198803.

ReferenceCitation: Dieterich D, Nelson M, Soriano V, Arastéh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon α-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.

ReferenceCitation: Ferenci P, Asselah T, Foster GR, Zeuzem S, Sarrazin C, Moreno C, Ouzan D, Maevskaya M, Calinas F, Morano LE, Crespo J, Dufour JF, Bourlière M, Agarwal K, Forton D, Schuchmann M, Zehnter E, Nishiguchi S, Omata M, Kukolj G, Datsenko Y, Garcia M, Scherer J, Quinson AM, Stern JO; STARTVerso1 Study Group. STARTVerso1: A randomized trial of faldaprevir plus pegylated interferon/ribavirin for chronic HCV genotype-1 infection. J Hepatol. 2015 Jun;62(6):1246-55. doi: 10.1016/j.jhep.2014.12.024. Epub 2015 Jan 2.

location_country:
Portugal
Romania
Spain
United Kingdom
Austria
Russian Federation
Switzerland
France
Belgium
Japan
Germany

location_facility: 1220.30.3314 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8117 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4304 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4408 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.7004 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8112 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4101 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8106 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8110 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8105 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4908 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3505 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8121 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4103 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3305 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3301 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4907 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4002 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3506 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8102 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3408 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3302 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4909 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3202 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4904 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4901 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4912 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3309 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3502 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8118 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4409 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4401 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4914 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3504 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.7006 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4917 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4004 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3404 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3311 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8114 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3201 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4301 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3304 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.7007 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3401 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8113 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8101 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4003 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8111 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.7001 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8119 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4405 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3207 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4915 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8122 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4303 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4916 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3312 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8115 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3303 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4001 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4106 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4410 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3203 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4911 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3407 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4107 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8116 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3405 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3503 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3316 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8107 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3315 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3507 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4407 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4903 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3204 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4302 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8104 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4906 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3509 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4406 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3403 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3205 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3402 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4403 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3313 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4913 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8109 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3501 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.7002 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4404 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8108 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4108 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.7005 Boehringer Ingelheim Investigational Site


title: A 10 Month Open-Label Evaluation Of The Long-Term Safety Of DVS-233 SR In Outpatients With Major Depressive Disorder.

summary: The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR) during open-label treatment in adult outpatients who had a primary diagnosis of major depressive disorder (MDD). The study also evaluated the long-term response of subjects receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and absence of depressive symptoms (remission).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Tourian KA, Pitrosky B, Padmanabhan SK, Rosas GR. A 10-month, open-label evaluation of desvenlafaxine in outpatients with major depressive disorder. Prim Care Companion CNS Disord. 2011;13(2). pii: PCC.10m00977. doi: 10.4088/PCC.10m00977blu.

lead_sponsor: Pfizer

location_country:
Poland
Latvia
Estonia
Finland
Lithuania
Former Serbia and Montenegro
United States
France
South Africa
Germany
Slovakia

location_facility: Inventiva Biomedical and Sport Research Sp. z o.o.

location_facility: Capital Clinical Research Associates, LLP

location_facility: California Clinical Trials Medical Group, Inc.

location_facility: Atlanta Institute of Medicine & Research

location_facility: Turku Psychiatric Services Aurakatu 14 B 3 Krs

location_facility: Psychiatrische Praxis Dr. Hans-Peter Wunderlich

location_facility: Praxis f. Neurologie u. Psychiatrie Dr. Lutz D. Lohse

location_facility: Wojewodzki Osrodek Lecznictwa Psychiatrycznego w Toruniu

location_facility: Riga Mental Health Care Center, Dept of Psychiatry

location_facility: Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych

location_facility: UCSD Department of Psychiatry Psychopharmacology Research

location_facility: Kolin Research Group 1065 West Morse Blvd. Suite 202

location_facility: Specjalistyczny Psychiatryczny ZOZ w Lodzi

location_facility: Southeastern Pennsylvania Medical Institute

location_facility: Viljandi Hospital Foundation Psychiatric Clinic

location_facility: The George Washington University Medical Center

location_facility: Poradnia Zdrowia Psychicznego w Chelmnie

location_facility: Psychoneurological hospital of Jelgava, Dept No12

location_facility: Nemocnica s poliklinikou Liptovsky Mikulas

location_facility: SP ZOZ Swietokrzyskie Centrum Psychiatrii w Morawicy

location_facility: Praxis für Psychiatrie, Dr. Alexander Schulze

location_facility: Klinicko-bolnicki centar Dr Dragisa Misovic - Dedinje

location_facility: Pivotal Research Centers 13128 North 94th Drive, Suite 200

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ipd_sharing: Yes

primary_purpose: Prevention

acronym: ADVANCE

title: Investigating New Onset Diabetes Mellitus in Kidney Transplant Recipients Receiving an Advagraf-Based Immunosuppressive Regimen With or Without Corticosteroids - A Multicenter, Two Arm, Randomized, Open Label Clinical Study

lead_sponsor: Astellas Pharma Inc

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

ReferenceCitation: Mourad G, Glyda M, Albano L, Viklický O, Merville P, Tydén G, Mourad M, Lõhmus A, Witzke O, Christiaans MHL, Brown MW, Undre N, Kazeem G, Kuypers DRJ; Advagraf-based immunosuppression regimen examining new onset diabetes mellitus in kidney transplant recipients (ADVANCE) study investigators. Incidence of Posttransplantation Diabetes Mellitus in De Novo Kidney Transplant Recipients Receiving Prolonged-Release Tacrolimus-Based Immunosuppression With 2 Different Corticosteroid Minimization Strategies: ADVANCE, A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1924-1934. doi: 10.1097/TP.0000000000001453.

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

location_country:
Spain
Italy
Lithuania
Belgium
Romania
Czechia
Poland
Portugal
Russian Federation
Australia
Mexico
Norway
Sweden
Slovakia
Switzerland
Hungary
Germany
Latvia
Estonia
Finland
Korea, Republic of
France
Colombia
Netherlands

summary: The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFα-Kinoid in Adult Subjects With Crohn's Disease

summary:
The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising.

The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

lead_sponsor: Neovacs

location_country:
Croatia
Romania
Netherlands
Czech Republic
Hungary
France
Belgium
Germany
Bulgaria

location_facility: Fővárosi Önkormányzat Péterfy Sándor utcai Kórháza

location_facility: Universitätsklinik und Poliklinik für Innere Medizin I

location_facility: Clinic of Gastroenterology/ University Hospital Varna

location_facility: Abteilung Innere Medizin Evangelisches Krankenhaus Kalk gGmbH

location_facility: Klinik für Innere Medizin II Abteilung Gastroenterologie, Hepatologie, Infektiologie

location_facility: Hamburgisches Forschungsinstitut für CED

location_facility: Free University Medical Centre in Amsterdam (VUMC)

location_facility: University Multiprofile Hospital St. Georgi

location_facility: Gastroenterologische Gemeinschaftspraxis im Ärztehaus am Ev. Krankenhaus Herne

location_facility: Medical Institute- Ministry of Interior Clinic of Gastroenterology

location_facility: I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf

location_facility: Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten

location_facility: Klinik mit Schwerpunkt Gastroenterologie, Campus Charité Mitte

location_facility: Klinik für Allg. Innere Medizin, Gastroenterologie und Diabetologie, Kliniken-Essen-Mitte/Evang. Huyssenstiftung

intervention_type: Biological


title: OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

acronym: OASIS

summary: Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.

status: Suspended

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Vincent JL, Marshall JC, Dellinger RP, Simonson SG, Guntupalli K, Levy MM, Singer M, Malik R; Oral tAlactoferrin in Severe sepsIS Study Investigators. Talactoferrin in Severe Sepsis: Results From the Phase II/III Oral tAlactoferrin in Severe sepsIS Trial. Crit Care Med. 2015 Sep;43(9):1832-8. doi: 10.1097/CCM.0000000000001090.

lead_sponsor: Agennix

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

location_facility: Klinikum der Johann-Wolfgang Goethe-Universität

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries

location_facility: University of Oklahoma Health Science Center

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Klinikum der Friedrich-Schiller-Universität Jena

status_simplified: Unknown


acronym: SAILING

title: A Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults

lead_sponsor: ViiV Healthcare

ReferenceType: background

ReferenceCitation: Cahn P, Pozniak AL, Mingrone H, Shuldyakov A, Brites C, Andrade-Villanueva JF, Richmond G, Buendia CB, Fourie J, Ramgopal M, Hagins D, Felizarta F, Madruga J, Reuter T, Newman T, Small CB, Lombaard J, Grinsztejn B, Dorey D, Underwood M, Griffith S, Min S; extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013 Aug 24;382(9893):700-8. doi: 10.1016/S0140-6736(13)61221-0. Epub 2013 Jul 3. Erratum in: Lancet. 2014 Jan 4;383(9911):30.

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

location_country:
Poland
Taiwan
Brazil
Romania
Spain
Greece
Italy
Australia
Mexico
Argentina
Canada
Russian Federation
United Kingdom
Hungary
United States
Chile
France
South Africa
Belgium
Netherlands

summary: ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.


acronym: SABRINA

title: A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Davies A, Merli F, Mihaljević B, Mercadal S, Siritanaratkul N, Solal-Céligny P, Boehnke A, Berge C, Genevray M, Zharkov A, Dixon M, Brewster M, Barrett M, MacDonald D. Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial. Lancet Haematol. 2017 Jun;4(6):e272-e282. doi: 10.1016/S2352-3026(17)30078-9. Epub 2017 May 2.

ReferenceCitation: Davies A, Merli F, Mihaljevic B, Siritanaratkul N, Solal-Céligny P, Barrett M, Berge C, Bittner B, Boehnke A, McIntyre C, Macdonald D. Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol. 2014 Mar;15(3):343-52. doi: 10.1016/S1470-2045(14)70005-1. Epub 2014 Feb 10.

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

ReferenceCitation: Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013 Sep 17;109(6):1556-61. doi: 10.1038/bjc.2013.371. Epub 2013 Sep 3.

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: UKSH Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Specialised Hospital For Treatment Of Hematological Diseases; Hematology

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

location_facility: Siriraj Hospital; Division of Hematology, Department of Medicine

location_facility: National Cancer Inst. ; Dept. of Chemotherapy

location_facility: Hospital Duran i Reynals; Servicio de Hematologia

location_facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

location_facility: University Clinical Centre Tuzla, Clinic for Oncology, Hematology and Radiotherapy

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Hospital General De Culiacan; Servicio De Hematologia

location_facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie

location_facility: Gemeinschaftspraxis PD Dr. med. Marcel Reiser und Dr. med. Ildiko Kátay

location_facility: University Malaya Medical Center; Hematology Unit of Department of Internal Medicine

location_facility: Research Inst. of Hematology & Blood Transfusion ; Hematology

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin

location_facility: Vejle Hospital; Dept of Medicine, Division of Hematology

location_facility: Canterbury Health Laboratories; Haematology

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Bilim University School of Medicine; Hematology

location_facility: Singapore General Hospital; Department of Haematology

location_facility: Institut J Paolii Calmettes; Onco Hematologie 1

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

location_facility: University Clinical Center Sarajevo, Clinic for Hematology

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

location_facility: Hopital Saint Eloi; Hematologie Oncologie Medicale

location_facility: King Edward VIII; Department of Haematology

location_facility: Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Hospital Universitario Puerta del Mar; Servicio de Hematologia

location_facility: Aarhus Universitetshospital, Hæmatologisk Afdeling R

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie

location_facility: National Cancer Centre; Medical Oncology

location_facility: Odense Universitetshospital; Hæmatologisk Afdeling

location_facility: Ospedale Di Vicenza; Nefrologia, Ematologia

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

location_facility: Ampang Hospital; Department of Haematology

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Herlev Uni Hospital; Hæmatologisk Afdeling L 121

location_facility: St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2

location_facility: Nucleo de Hematologia e Transplante de Medula Ossea de Minas Gerais

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

location_facility: Fundeni Clinical Inst. ; Hematology Dept

location_facility: Hospital Ramon y Cajal; Servicio de Hematologia

location_facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

location_facility: Centro de Estudios Clinicos de Queretaro (CECLIQ)

location_facility: Ospedale S. Eugenio; Divisione Di Ematologia

location_facility: University Clinic of Hematology Skopje, Hospital Care Department

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: Haematology Research Center; Haematology

location_facility: AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia

location_facility: Praxis Dr. Clemens Müller-Naendrup (Onkologische Schwerpunktpraxis im MVZ 2 GmbH)

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia

location_facility: Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

location_facility: CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

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

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie

location_facility: Caritas Kilinik St. Theresia; Abt. Innere Medizin

location_facility: Centre de sante et de services sociaux Rimouski Neigette

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department

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

location_facility: University Hospital Center Zagreb; Haematology Department

location_facility: Institute of Hematology and Transfusiology

location_facility: Ninewells Hospital & Medical School; Ward 34

location_facility: Derriford Hospital; Department of Haematology

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Gold Coast Hospital; Haematology Department

location_facility: PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann

location_facility: Clinical Center Vojvodine; Clinic for Hematology

location_facility: Chemotherapy and Immunotherapy Clinic Medulla

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

location_facility: University of Witwatersrand/Johannesburg Hospital; Dept. of ocnology

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Palmerston North Hospital; Regional Cancer Treatment Service

location_facility: University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept

location_facility: Hospital del Mar; Servicio de Hematologia

location_facility: Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I

location_facility: Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.

location_facility: Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

location_facility: Uni Degli Studi Di Genova; 1A Divisione Di Ematologia

location_facility: University Clinic for Hematology; HSCT Department

location_facility: Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Centre hospitalier regional de Trois-Rivieres

location_facility: Pinderfields General Hospital; Dept of Haematology

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia

location_facility: New Cross Hospital; Dept. Of Haematology

location_facility: Azienda Ospedaliera Ospedale S.Carlo; Ematologia

location_facility: Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

summary: This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.


title: A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

acronym: DESKTOPIII

summary: It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operationThe goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients.

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Harter P, Sehouli J, Vergote I, Ferron G, Reuss A, Meier W, Greggi S, Mosgaard BJ, Selle F, Guyon F, Pomel C, Lécuru F, Zang R, Avall-Lundqvist E, Kim JW, Ponce J, Raspagliesi F, Kristensen G, Classe JM, Hillemanns P, Jensen P, Hasenburg A, Ghaem-Maghami S, Mirza MR, Lund B, Reinthaller A, Santaballa A, Olaitan A, Hilpert F, du Bois A; DESKTOP III Investigators. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer. N Engl J Med. 2021 Dec 2;385(23):2123-2131. doi: 10.1056/NEJMoa2103294. Erratum in: N Engl J Med. 2022 Feb 17;386(7):704.

ReferenceCitation: Bommert M, Harter P, Heitz F, du Bois A. When should Surgery be used for Recurrent Ovarian Carcinoma? Clin Oncol (R Coll Radiol). 2018 Aug;30(8):493-497. doi: 10.1016/j.clon.2018.04.006. Epub 2018 May 7. Review.

lead_sponsor: AGO Study Group

location_country:
Denmark
Spain
Italy
Austria
United Kingdom
Sweden
Korea, Republic of
France
China
Belgium
Norway
Germany

location_facility: Zhejiang Cancer Hospital, Gynecology Oncology

location_facility: Klinikum der Universität München-Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

location_facility: HSK, Dr. Horst Schmidt Klinik GmbH, Klinik für Gynäkologie u. Gynäkologische Onkologie

location_facility: Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe

location_facility: Klinikum der JWG Universität Frankfurt, Klinik für Gynäkologie und Geburtshilfe

location_facility: Royal Surrey Country Hospital,St Lukes Cancer Centre

location_facility: Birmingham City Hospital, Cancer Research Team

location_facility: Linköping University Hospital, Department of Obstetrics and Gynecology

location_facility: Hospital de la Santa Creu i Sant Pau, Oncology

location_facility: Istituto Nazionale Tumori di Napoli, Gynecologic Oncology

location_facility: ICO Badalona - H. U. Germans Trias i Pujol

location_facility: Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde

location_facility: University College London Hospital, Cancer clinical trails unit

location_facility: Royal Marsden NHS Foundation Trust, Gynae research, Mulberry House

location_facility: Fondazione IRCCS Istituto Nazionale Tumori di Milano

location_facility: Queen Elizabeth the Queen Mother Hospital,East Kent Gynaeoncology Centre

location_facility: Nottingham University Hospital, City Campus, Oncology

location_facility: Kaiserswerther-Diakonie, Florence-Nightingale Krankenhaus, Gynäkologie

location_facility: Imperial College Healthcare NHS Trust Hammersmith Hospital, Medical Oncology

location_facility: Avinguda Granvia de l'Hospitalet de Llobregat, Hospital de Bellvitge, Gynaecology

location_facility: Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe

location_facility: Norfolk & Norwich University Hospital,Obstetrics & Gynaecology

location_facility: Insitut Jean Godinot, Service Rubis - Oncologie Médicale

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Fudan University Cancer Hospital, Gynecologic Oncology

location_facility: Royal Hallamshire Hospital & Weston Park Hospital, Cancer Clinical Trials Centre

location_facility: Klinikum Fürth, Frauenklinik Nathanstift

location_facility: Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Frauenklinik

location_facility: Medizinische Hochschule, Klinik für Frauenheilkunde u. Geburtshilfe

location_facility: Gynecologic Clinic of the Ernst-Moritz-Arndt-University

location_facility: Centre Hospitalier Universitaire Charles-Nicolle

location_facility: Ringshospitalet Copenhagen University Hospital; Oncology

location_facility: Hospital Universitari i Politècnic la Fe, Oncology

location_facility: Norwegian Radium Hospital, Oslo University Hospital, Gynecologic Oncology

location_facility: Cambridge University Hospitals NHS FT - Addenbrookes Hospital, Gynaecological Oncology

location_facility: Odense University Hospital, Gynaecology and Obstetrics

location_facility: Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Gynäkologische Onkologie

location_facility: Northampton General Hospital, Gynaecological Oncology

location_facility: Karolinska University Hospital, Oncology

location_facility: Fundación Instituto Valenciano de Oncologia

location_facility: Klinikum Kempten, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe d. Universität Regensburg

location_facility: Suzhou Municipal Hospital, Gynecologic and Obstetrics

location_facility: Queen Elizabeth Hospital Gateshead, Northern gynaecological oncology centre

location_facility: Klinikum Dritter Orden, Gynäkologie und Geburtshilfe

location_facility: Oberschwaben Klinik, Krankenhaus St. Elisabeth, Frauenklinik

location_facility: East and North Hertfordhire NHS Trust,Mount Vernon Hospital,Medical Oncology

location_facility: Fudan University Zhongshan Hospital, Obstetrics and Gynecology

location_facility: Central Manchester Foundation NHS Trust, St Mary´s Hospital, Gynaecology

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe

location_facility: Centro di Riferimento Oncologico,Struttura Operativa complessa Chirurgia Oncologica Ginecologica

location_facility: St Bartholomew´s Hospital and Queen´s Hospital,Gynaecological Cancer Centre

location_facility: Istituto Europeo di Oncologia, Divisione di Ginecologia

location_facility: ICO-Hospital Universitari de Girona Dr. Josep Trueta, Servicio de Oncologia de Girona

location_facility: Universitätsklinikum Carl Gustav Carus, Klinik für Frauenheilkunde u. Geburtshilfe

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde

location_facility: Seoul National University Hospital, Department of Obstetrics and Gynecology

location_facility: Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung

intervention_type: Procedure


acronym: LUX-Breast 1

title: LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Harbeck N, Huang CS, Hurvitz S, Yeh DC, Shao Z, Im SA, Jung KH, Shen K, Ro J, Jassem J, Zhang Q, Im YH, Wojtukiewicz M, Sun Q, Chen SC, Goeldner RG, Uttenreuther-Fischer M, Xu B, Piccart-Gebhart M; LUX-Breast 1 study group. Afatinib plus vinorelbine versus trastuzumab plus vinorelbine in patients with HER2-overexpressing metastatic breast cancer who had progressed on one previous trastuzumab treatment (LUX-Breast 1): an open-label, randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):357-366. doi: 10.1016/S1470-2045(15)00540-9. Epub 2016 Jan 26.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Peru
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Singapore
Slovakia
Egypt
Brazil
Lebanon
Sri Lanka
Canada
China
Germany
Taiwan
Belarus
Ireland
Latvia
Korea, Republic of
France
Chile
Netherlands

location_facility: Wojewodzki Specialist Hospital No. 4, Bytom

location_facility: METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht

location_facility: N.A. Semashko Central Clinical Hospital, Moscow

location_facility: The Third Affiliated Hospital of Harbin Medical University

location_facility: Instituto Português de Oncologia de Coimbra Francisco Gentil

location_facility: N. N. Alexandrov National Cancer Center of Belarus

location_facility: Ziemia Lubelska Oncological Center, Lublin

location_facility: Provincial Specialist M. Kopernik Hospital

location_facility: Máxima Medisch Centrum, locatie Eindhoven

location_facility: Instituto Clínico Oncológico del Sur - ICOS

location_facility: Universitätsfrauenklinik am Klinikum Südstadt

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc

location_facility: Centro de Referência da Saude da Mulher-Hosp Perola Byington

location_facility: Instituto Medico de Asistencia e Investigaciones S. A.

location_facility: Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: POKO Policlinic Dept. of Clinical Oncology

location_facility: Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie

location_facility: Oncology Centre of Olsztyn "KOPERNIK" Sp. z.o.o.

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Cancer Hospital of Chinese Academy of Medical Science

location_facility: Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Gynäk.-onkol. Gem.praxis, Dr. Uleer, Hildesheim

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: CHU de Quebec-Universite Laval Research Centre

location_facility: DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU

location_facility: St. Jacobs Hosp.Outpat.Pneumology&Phthisiology Dept,Bardejov

location_facility: Centro de Pesquisas Clínicas em Oncología

location_facility: Public Health Inst. Minsk City Clinical Oncology Dispensary

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: Central Coast Medical Oncology Corporation

location_facility: Cancer Care Associates Medical Group, Inc

location_facility: St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

location_facility: P. Stradins Clinical Univ. Hospital, Oncology Clinic

location_facility: Riga East Univ. Hospital, Oncology Centre

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: GUZ "Regional Clinical Oncology Dispensary"

location_facility: Koo Foundation Sun Yet-Sen Cancer Center

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: National Institute of Oncology, Bratislava

location_facility: Johns Hopkins Singapore International Medical Center

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: CHUC, EPE - CHC-Maternidade Bissaya Barreto

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Hammoud Hospital University Medical Centre (HHUMC)

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Complejo Hospitalario Universitario Insular - Materno Infantil

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

summary: To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment


title: A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer

ReferenceCitation: Perez EA, de Haas SL, Eiermann W, Barrios CH, Toi M, Im YH, Conte PF, Martin M, Pienkowski T, Pivot XB, Burris HA 3rd, Stanzel S, Patre M, Ellis PA. Relationship between tumor biomarkers and efficacy in MARIANNE, a phase III study of trastuzumab emtansine ± pertuzumab versus trastuzumab plus taxane in HER2-positive advanced breast cancer. BMC Cancer. 2019 May 30;19(1):517. doi: 10.1186/s12885-019-5687-0. Erratum in: BMC Cancer. 2019 Jun 24;19(1):620.

ReferenceCitation: Bighin C, Pronzato P, Del Mastro L. Trastuzumab emtansine in the treatment of HER-2-positive metastatic breast cancer patients. Future Oncol. 2013 Jul;9(7):955-7. doi: 10.2217/fon.13.74.

ReferenceCitation: Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236. Review.

location_facility: Nebraska Methodist Hospital; Cancer Center

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

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

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Okayama University Hospital; Breast, Thyroid Surgery

location_facility: Showa University Hospital; Breast Surgery

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Kanazawa University Hospital; Breast Oncology

location_facility: Sharp Healthcare; Oncology Research Program

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Cluj Clinical County Hospital; Oncology Dept

location_facility: Peterborough City Hospital; Oncology Ward

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: The Don & Sybil Harrington Cancer Center; Department of Clinical Research

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Mater Misericordiae Hospital; Chemotherapy Cottage

location_facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

location_facility: Tokai University Hospital, Breast and Endocrine Surgery

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Nordsjællands Hospital, Hillerød, Onkologisk Afdeling

location_facility: Centro Catanese Di Oncologia; Oncologia Medica

location_facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Northeast Georgia Medical Center; Oncology Research Dept-5C

location_facility: Gifu University Hospital; Second Department of Surgery

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Washington Cancer Institute; Washington Hospital Center

location_facility: Maharaj Nakorn Hospital; Internal Medicine

location_facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

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

location_facility: Institut de Cancerologie de La Loire; Radiotherapie

location_facility: University Hospital of Larissa; Oncology

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Natl Hosp Org Shikoku; Cancer Ctr, Surgery

location_facility: Gazi Uni Medical Faculty Hospital; Oncology Dept

location_facility: The Cancer Inst. Hosp. of JFCR; Breast Oncology Center

location_facility: Waikato Hospital; Regional Cancer Center

location_facility: Changhua Christian Hospital; Hematology-Oncology

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Kitakyushu Municipal Medical Center; Surgery

location_facility: Uni of Texas Southwestern Medical Center

location_facility: Shizuoka Cancer Center; Female Internal Medicine

location_facility: Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

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

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Centro de Investigacion; Clinica Del Pacifico

location_facility: Cancer Research Center of Hawaii; Clinical Sciences

location_facility: Centro Oncológico Estatal; ISSSEMYM Oncología

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

location_facility: Cebu Cancer Institute; Perpetual Succour Hospital

location_facility: Universitätsklinikum Magdeburg; Frauenheilkunde & Geburtshilfe

location_facility: James Graham Brown Cancer Center, University of Louisville

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center

location_facility: Centre Rene Huguenin; ONCOLOGIE GENETIQUE

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Kumamoto University Hospital; Breast and Endocrine Surgery

location_facility: Mercy Medical Center; Medical Oncology & Hematology

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Aichi Cancer Center Hospital, Breast Oncology

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Jichi Medical University; Breast Oncology

location_facility: St. John'S Mercy Medical Center; David C. Pratt Cancer Center

location_facility: Instituto Colombiano Para El Avance De La Medicina: Icamedic

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Ospedale Degli Infermi; Divisione Di Oncologia

location_facility: Kawasaki Medical School Hospital; Breast and Thyroid Surgery

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Saitama Medical University International Medical Center; Medical Oncology

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica

location_facility: Kantonsspital Baden; Medizinische Klinik, Onkologie

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Toranomon Hospital; Breast and Endocrine Surgery

location_facility: Osaka University Hospital; Breast and Endocrine Surgery

location_facility: St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Tohoku University Hospital; Breast And Endocrine Surgery

location_facility: Gunma University Hospital; Department of Breast and Endocrine Surgery

location_facility: Ospedale Papardo- Piemonte;Oncologia Medica

location_facility: Cuse - Centre Universitaire De Sante; Site Fleurimont

location_facility: Cukurova Uni Faculty of Medicine; Medical Oncology

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: National Hospital Organization Hokkaido Cancer Center; Breast Surgery

location_facility: National Hospital Organization Osaka National Hospital; Breast Surgery

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Korea University Guro Hospital; Oncology

location_facility: Private Health Organization Acibadem Sistina Hospital

location_facility: GUZ Vladimir Regional Clinical Oncological Dispensary

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Columbia Comprehensive Cancer Center Clinic

location_facility: Mikawa Breast Cancer Clinic; Breast Surgery

location_facility: Niigata Cancer Ctr Hospital; Breast Surgery

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Oncology Associates at Mercy Medical Center

location_facility: Uni of Colorado Cancer Center; Anschutz Cancer Pavilion

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: The Providence Regional Medical Center Everett

location_facility: Hiroshima University Hospital; Breast Surgery

location_facility: Kyorin University Hospital; Breast Surgery

location_facility: CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY

location_facility: Innovative Medical Research of South Florida

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

location_facility: National Cancer Center Hospital; Breast and Medical Oncology

location_facility: Prince of Songkla Uni ; Unit of Medical Oncology

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: A.O. Universitaria Policlinico Di Modena; Ematologia

location_facility: Tri-Service General Hospital; Hematology and Oncology

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Tokyo Medical Uni. Hospital; Breast Oncology

location_facility: Shizuoka General Hospital; Breast Surgery

location_facility: South Carolina Oncology Associates - SCRI

location_facility: Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie

location_facility: Kyoto University Hospital; Breast Surgery

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

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Southampton General Hospital; Somers Cancer Research Building

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

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

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Ryazan State Medical University Named after I.P.Pavlov

location_facility: University of California; Moores Cancer Center

location_facility: Hopital Saint Louis; Service Onco Thoracique

location_facility: Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center

location_facility: Providence St. Mary Regional Cancer Center

location_facility: Uni Hospital of North Staffordshire; Staffordshire Oncology Centre

location_facility: Centrum Onkologii, Instytut, Klinika Chemioterapii; Oddzial Chemoterapii

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Wesley Medical Centre; Clinic For Haematology and Oncology

location_facility: Seoul National University Bundang Hospital; Hematology Medical Oncology

location_facility: Hyogo College Of Medicine; Breast And Endocrine Surgery

location_facility: Little Rock Hematology Oncology Associates, PA

location_facility: Pantai Hospital Kuala Lumpur; Dept of Oncology & Radiotherapy

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Hackensack Uni Medical Center; Northern Nj Cancer Center

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

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Kumamoto City Hospital, Breast and Endocrine Surgery

location_facility: Arcispedale Santa Maria Nuova; Oncologia

summary: This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.


status: Terminated

acronym: A+B

title: Randomized Open Label of Ofatumumab and Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment

lead_sponsor: Novartis Pharmaceuticals

type: Other Identifier

ReferenceCitation: Rummel MJ, Janssens A, MacDonald D, Keating MM, Zaucha JM, Davis J, Lasher J, Babanrao Pisal C, Izquierdo M, Friedberg JW. A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab-refractory iNHL (COMPLEMENT A + B study). Br J Haematol. 2021 Jun;193(6):1123-1133. doi: 10.1111/bjh.17420. Epub 2021 May 10.

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

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

location_country:
Poland
Hong Kong
United Kingdom
Greece
Austria
Italy
Russian Federation
Argentina
Canada
Ukraine
Puerto Rico
United States
France
Belgium
Japan
Germany
Slovakia

summary: The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.


acronym: PROLONG

title: A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy

location_country:
Spain
Italy
Ukraine
United States
Belgium
Czechia
Poland
Russian Federation
Australia
Argentina
Puerto Rico
India
Israel
Turkey
Norway
Sweden
Brazil
Canada
Hungary
Denmark
Greece
Finland
Korea, Republic of
France
Netherlands

summary: The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.


title: Attain Success Clinical Trial

summary: The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Poland
Taiwan
Hong Kong
Romania
Canada
Thailand
Puerto Rico
United States
France
China
India
Malaysia
Malta
Germany
Singapore
Pakistan

intervention_type: Device


title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects With Premature Ejaculation

summary: The purpose of this clinical trial is to test an experimental drug therapy called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HCl ODT" or the "study drug"). The subject and his partner are being asked to be in this clinical trial because they have a condition called premature ejaculation.

ReferenceCitation: Bar-Or D, Salottolo KM, Orlando A, Winkler JV; Tramadol ODT Study Group. A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2 minutes. Eur Urol. 2012 Apr;61(4):736-43. doi: 10.1016/j.eururo.2011.08.039. Epub 2011 Aug 30.

lead_sponsor: Bausch Health Americas, Inc.

location_country: Spain Austria Netherlands Sweden France Belgium Germany

location_facility: Universitair Ziekenhuls Antwerpen (UZA), Wirjkstraat 10

location_facility: Ziekenhuisnelwerk Antwerpen (ZNA), Campus Stuvenberg-St. Erasmus

location_facility: Medizinische Hochschule Hannover Zentrum for Seelische Gesundhelt

location_facility: Clinique St. Jean, Depart. of Urology, Blvd du Jardin Botanique, 32

location_facility: Abetellung for Andrologie & Urologie PAN-Kilnik am Neumarkt

location_facility: PUR/R Praxisklinik Urologie 3 Rhein Ruhr

location_facility: Academic Medical Center, Depart. of Urology

location_facility: Hospital Universitario Fundacion Alcordon

location_facility: CHU de Nimes-Groupe Hospitalo-Universitaire, Pharmacie Secteur Essals Cliniques,

location_facility: Hopital Raymond Poincar'e, 104 Bvld. Raymond Poincar'e

location_facility: Institut fur Mannergesundheit Universitakslinikum Hamburg-Eppendorf


acronym: PREDICT

title: GSK2132231A Antigen-Specific Cancer Immunotherapeutic as First-line Treatment of Patients With Unresectable Metastatic Melanoma

lead_sponsor: GlaxoSmithKline

ReferenceCitation: Saiag P, Gutzmer R, Ascierto PA, Maio M, Grob JJ, Murawa P, Dreno B, Ross M, Weber J, Hauschild A, Rutkowski P, Testori A, Levchenko E, Enk A, Misery L, Vanden Abeele C, Vojtek I, Peeters O, Brichard VG, Therasse P. Prospective assessment of a gene signature potentially predictive of clinical benefit in metastatic melanoma patients following MAGE-A3 immunotherapeutic (PREDICT). Ann Oncol. 2016 Oct;27(10):1947-53. doi: 10.1093/annonc/mdw291. Epub 2016 Aug 8.

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below)

location_country:
Poland
Spain
Italy
Ireland
Russian Federation
United States
France
Germany

summary: The objective of this study is to evaluate the clinical activity of the GSK2132231A immunotherapeutic in patients with MAGE-A3 positive unresectable metastatic melanoma presenting with the predictive gene signature.


title: A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)

acronym: BRISK TA

summary: The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.

lead_sponsor: Bristol-Myers Squibb

location_country:
Taiwan
Hong Kong
Spain
Italy
Australia
Argentina
Canada
Thailand
Korea, Republic of
United States
France
China
Japan

location_facility: The University Of Texas MD Anderson Cancer Center

intervention_type: Other


title: A Postauthorization Safety Surveillance Study Of Patients Switching To ReFacto AF From ReFacto Or Other Factor VIII Products In Usual Care Settings

location_country:
Denmark
Romania
Spain
Greece
Austria
Italy
Netherlands
Finland
United Kingdom
Sweden
Hungary
France
Belgium
Germany

summary: The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.


type: U.S. NIH Grant/Contract

title: Strategic Timing of AntiRetroviral Treatment

acronym: START

summary:
Objectives:

To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines.
To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.

ReferenceCitation: Babiker AG, Emery S, Fätkenheuer G, Gordin FM, Grund B, Lundgren JD, Neaton JD, Pett SL, Phillips A, Touloumi G, Vjechaj MJ; INSIGHT START Study Group. Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study. Clin Trials. 2013;10(1 Suppl):S5-S36. doi: 10.1177/1740774512440342. Epub 2012 Apr 30.

ReferenceCitation: INSIGHT START Study Group, Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, Avihingsanon A, Cooper DA, Fätkenheuer G, Llibre JM, Molina JM, Munderi P, Schechter M, Wood R, Klingman KL, Collins S, Lane HC, Phillips AN, Neaton JD. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807. doi: 10.1056/NEJMoa1506816. Epub 2015 Jul 20.

ReferenceCitation: Gabrielaite M, Bennedbæk M, Zucco AG, Ekenberg C, Murray DD, Kan VL, Touloumi G, Vandekerckhove L, Turner D, Neaton J, Lane HC, Safo S, Arenas-Pinto A, Polizzotto MN, Günthard HF, Lundgren JD, Marvig RL. Human Immunotypes Impose Selection on Viral Genotypes Through Viral Epitope Specificity. J Infect Dis. 2021 Dec 15;224(12):2053-2063. doi: 10.1093/infdis/jiab253.

ReferenceCitation: Ghazi L, Baker JV, Sharma S, Jain MK, Palfreeman A, Necsoi C, Murray DD, Neaton JD, Drawz PE. Role of Inflammatory Biomarkers in the Prevalence and Incidence of Hypertension Among HIV-Positive Participants in the START Trial. Am J Hypertens. 2020 Jan 1;33(1):43-52. doi: 10.1093/ajh/hpz132.

ReferenceCitation: Lampe FC, Rodger AJ, Burman W, Grulich A, Friedland G, Sadr WE, Neaton J, Corbelli GM, Emery S, Molina JM, Orkin C, Gatell J, Gerstoft J, Ruxrungtham K, Barbosa de Souza M, Phillips AN; INSIGHT START Study Group. Impact of early antiretroviral treatment on sexual behaviour: a randomised comparison. AIDS. 2019 Dec 1;33(15):2337-2350. doi: 10.1097/QAD.0000000000002359.

ReferenceCitation: Wyman Engen N, Huppler Hullsiek K, Belloso WH, Finley E, Hudson F, Denning E, Carey C, Pearson M, Kagan J. A randomized evaluation of on-site monitoring nested in a multinational randomized trial. Clin Trials. 2020 Feb;17(1):3-14. doi: 10.1177/1740774519881616. Epub 2019 Oct 24.

ReferenceCitation: Castillo-Mancilla JR, Phillips AN, Neaton JD, Neuhaus J, Sharma S, Baker JV, Collins S, Mannheimer S, Pett S, Touzeau-Römer V, Polizzotto MN, Lundgren JD, Gardner EM; INSIGHT START Study Group. Incomplete ART adherence is associated with higher inflammation in individuals who achieved virologic suppression in the START study. J Int AIDS Soc. 2019 Jun;22(6):e25297. doi: 10.1002/jia2.25297.

ReferenceCitation: Borges ÁH, Neuhaus J, Sharma S, Neaton JD, Henry K, Anagnostou O, Staub T, Emery S, Lundgren JD; INSIGHT SMART; START Study Groups. The Effect of Interrupted/Deferred Antiretroviral Therapy on Disease Risk: A SMART and START Combined Analysis. J Infect Dis. 2019 Jan 7;219(2):254-263. doi: 10.1093/infdis/jiy442.

ReferenceCitation: Molina JM, Grund B, Gordin F, Williams I, Schechter M, Losso M, Law M, Ekong E, Mwelase N, Skoutelis A, Wiselka MJ, Vandekerckhove L, Benfield T, Munroe D, Lundgren JD, Neaton JD; INSIGHT START study group. Which HIV-infected adults with high CD4 T-cell counts benefit most from immediate initiation of antiretroviral therapy? A post-hoc subgroup analysis of the START trial. Lancet HIV. 2018 Apr;5(4):e172-e180. doi: 10.1016/S2352-3018(18)30003-1. Epub 2018 Jan 16.

ReferenceCitation: Ronit A, Sharma S, Baker JV, Mngqibisa R, Delory T, Caldeira L, Ndembi N, Lundgren JD, Phillips AN; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Strategic Timing of Antiretroviral Treatment (START) Study Group. Serum Albumin as a Prognostic Marker for Serious Non-AIDS Endpoints in the Strategic Timing of Antiretroviral Treatment (START) Study. J Infect Dis. 2018 Jan 17;217(3):405-412. doi: 10.1093/infdis/jix350.

ReferenceCitation: Baker JV, Sharma S, Achhra AC, Bernardino JI, Bogner JR, Duprez D, Emery S, Gazzard B, Gordin J, Grandits G, Phillips AN, Schwarze S, Soliman EZ, Spector SA, Tambussi G, Lundgren J; INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) START (Strategic Timing of Antiretroviral Treatment) Study Group. Changes in Cardiovascular Disease Risk Factors With Immediate Versus Deferred Antiretroviral Therapy Initiation Among HIV-Positive Participants in the START (Strategic Timing of Antiretroviral Treatment) Trial. J Am Heart Assoc. 2017 May 22;6(5). pii: e004987. doi: 10.1161/JAHA.116.004987.

ReferenceCitation: Grady C, Touloumi G, Walker AS, Smolskis M, Sharma S, Babiker AG, Pantazis N, Tavel J, Florence E, Sanchez A, Hudson F, Papadopoulos A, Emanuel E, Clewett M, Munroe D, Denning E; INSIGHT START Informed Consent Substudy Group. A randomized trial comparing concise and standard consent forms in the START trial. PLoS One. 2017 Apr 26;12(4):e0172607. doi: 10.1371/journal.pone.0172607. eCollection 2017.

ReferenceCitation: O'Connor J, Vjecha MJ, Phillips AN, Angus B, Cooper D, Grinsztejn B, Lopardo G, Das S, Wood R, Wilkin A, Klinker H, Kantipong P, Klingman KL, Jilich D, Herieka E, Denning E, Abubakar I, Gordin F, Lundgren JD; INSIGHT START study group. Effect of immediate initiation of antiretroviral therapy on risk of severe bacterial infections in HIV-positive people with CD4 cell counts of more than 500 cells per μL: secondary outcome results from a randomised controlled trial. Lancet HIV. 2017 Mar;4(3):e105-e112. doi: 10.1016/S2352-3018(16)30216-8. Epub 2017 Jan 5.

ReferenceCitation: Larson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.

ReferenceCitation: Carr A, Grund B, Neuhaus J, Schwartz A, Bernardino JI, White D, Badel-Faesen S, Avihingsanon A, Ensrud K, Hoy J; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Prevalence of and risk factors for low bone mineral density in untreated HIV infection: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:137-46. doi: 10.1111/hiv.12242.

ReferenceCitation: Matthews GV, Neuhaus J, Bhagani S, Mehta SH, Vlahakis E, Doroana M, Naggie S, Arenas-Pinto A, Peters L, Rockstroh JK; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Baseline prevalence and predictors of liver fibrosis among HIV-positive individuals: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:129-36. doi: 10.1111/hiv.12241.

ReferenceCitation: Kunisaki KM, Niewoehner DE, Collins G, Nixon DE, Tedaldi E, Akolo C, Kityo C, Klinker H, La Rosa A, Connett JE; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Pulmonary function in an international sample of HIV-positive, treatment-naïve adults with CD4 counts > 500 cells/μL: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:119-28. doi: 10.1111/hiv.12240.

ReferenceCitation: Baker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S, Duprez D; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:109-18. doi: 10.1111/hiv.12239.

ReferenceCitation: Wright EJ, Grund B, Cysique LA, Robertson KR, Brew BJ, Collins G, Shlay JC, Winston A, Read TR, Price RW; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Factors associated with neurocognitive test performance at baseline: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:97-108. doi: 10.1111/hiv.12238.

ReferenceCitation: Lifson AR, Grandits GA, Gardner EM, Wolff MJ, Pulik P, Williams I, Burman WJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Quality of life assessment among HIV-positive persons entering the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:88-96. doi: 10.1111/hiv.12237.

ReferenceCitation: Baxter JD, Dunn D, White E, Sharma S, Geretti AM, Kozal MJ, Johnson MA, Jacoby S, Llibre JM, Lundgren J; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Global HIV-1 transmitted drug resistance in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:77-87. doi: 10.1111/hiv.12236.

ReferenceCitation: Rodger AJ, Lampe FC, Grulich AE, Fisher M, Friedland G, Phanuphak N, Bogner JR, Pereira LC, Rietmeijer C, Burman W, Phillips AN; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Transmission risk behaviour at enrolment in participants in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:64-76. doi: 10.1111/hiv.12235.

ReferenceCitation: Achhra AC, Mocroft A, Ross MJ, Ryom L, Lucas GM, Furrer H, Neuhaus J, Somboonwit C, Kelly M, Gatell JM, Wyatt CM; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Kidney disease in antiretroviral-naïve HIV-positive adults with high CD4 counts: prevalence and predictors of kidney disease at enrolment in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:55-63. doi: 10.1111/hiv.12234.

ReferenceCitation: Soliman EZ, Sharma S, Arastéh K, Wohl D, Achhra A, Tambussi G, O'Connor J, Stein JH, Duprez DA, Neaton JD, Phillips A; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Baseline cardiovascular risk in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:46-54. doi: 10.1111/hiv.12233.

ReferenceCitation: Law MG, Achhra A, Deeks SG, Gazzard B, Migueles SA, Novak RM, Ristola M; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Clinical and demographic factors associated with low viral load in early untreated HIV infection in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:37-45. doi: 10.1111/hiv.12232.

ReferenceCitation: Sharma S, Babiker AG, Emery S, Gordin FM, Lundgren JD, Neaton JN, Bakowska E, Schechter M, Wiselka MJ, Wolff MJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:30-6. doi: 10.1111/hiv.12231.

ReferenceCitation: Denning E, Sharma S, Smolskis M, Touloumi G, Walker S, Babiker A, Clewett M, Emanuel E, Florence E, Papadopoulos A, Sánchez A, Tavel J, Grady C; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:24-9. doi: 10.1111/hiv.12230.

ReferenceCitation: Grarup J, Rappoport C, Engen NW, Carey C, Hudson F, Denning E, Sharma S, Florence E, Vjecha MJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Challenges, successes and patterns of enrolment in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:14-23. doi: 10.1111/hiv.12229.

ReferenceCitation: Geffen N, Aagaard P, Corbelli GM, Meulbroek M, Peavy D, Rappoport C, Schwarze S, Collins S; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Community Advisory Board. Community perspective on the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:10-3. doi: 10.1111/hiv.12228.

ReferenceCitation: INSIGHT Strategic Timing of AntiRetroviral Treatment (START) Study Group, Lundgren J, Babiker A, Gordin F, Emery S, Fätkenheuer G, Molina JM, Wood R, Neaton JD. Why START? Reflections that led to the conduct of this large long-term strategic HIV trial. HIV Med. 2015 Apr;16 Suppl 1:1-9. doi: 10.1111/hiv.12227.

ReferenceCitation: Kunisaki KM, Quick H, Baker JV. HIV antiretroviral therapy reduces circulating surfactant protein-D levels. HIV Med. 2011 Oct;12(9):580-1. doi: 10.1111/j.1468-1293.2011.00920.x.

lead_sponsor: University of Minnesota

location_country:
Luxembourg
Spain
Italy
United Kingdom
United States
Peru
Belgium
South Africa
Czechia
Poland
Portugal
Austria
Australia
Argentina
Puerto Rico
India
Israel
Mexico
Norway
Malaysia
Sweden
Brazil
Switzerland
Mali
Germany
Denmark
Greece
Ireland
Estonia
Nigeria
Finland
Thailand
Uganda
France
Chile
Morocco

location_facility: The Research and Education Group at Portland VA Research Foundation

location_facility: Hvidovre University Hospital, Department of Infectious Diseases

location_facility: Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS

location_facility: Hospital La Princesa, Internal Medicine and Infectious Disease Service CRS

location_facility: INCMNSZ (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran)

location_facility: SEI - Servi�os Especializados em Infectologia

location_facility: Asociacion Civil Impacta Salud y Educacion - Sede San Miguel

location_facility: New Jersey Medical School Adult Clinical Research Center

location_facility: Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS

location_facility: George Washington Medical Faculty Associates

location_facility: University of Puerto Rico Pediatric Research Site

location_facility: Centro de Referencia e Treinamento DST/Aids

location_facility: Walter Reed National Military Medical Center

location_facility: Institute of Human Virology-Nigeria (IHVN)

location_facility: Desmond Tutu HIV Foundation Clinical Trials Unit

location_facility: Sheffield Teaching Hospital NHS Foundation Trust

location_facility: Universitatsklinikum Wurzburg, Medizinische Klinik und Poliklinik II, Schwerpunkt Infektiologie CRS

location_facility: Puerto Rico-AIDS Clinical Trials Unit (PR-ACTU)

location_facility: National Institutes of Health Clinical Center

location_facility: Hospital Nacional Profesor Alejandro Posadas

location_facility: Community Research Initiative of New England

location_facility: Hospital Universitario Principe de Asturias

location_facility: Florida Department of Health in Orange County/Sunshine Care Center

location_facility: Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)

location_facility: Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Instituto de Infectologia Emilio Ribas - IIER

location_facility: Asociacion Civil IMPACTA Salud y Educacion

location_facility: Sexual Health and HIV Service - Clinic 2

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

location_facility: VA Greater Los Angeles Healthcare System

location_facility: West Tallinn Central Hospital Infectious Diseases

location_facility: Faculty Hospital Na Bulovce, Prague, Czech Rep.

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Khon Kaen University, Srinagarind Hospital

location_facility: Hospital Interzonal General de Agudos Dr. Diego Paroissien

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hillsborough County Health Deptment/University of South Florida

location_facility: University of Florida Health Services Center

location_facility: University of North Texas Health Science Center

location_facility: Rigshospitalet, Infektionsmedicinsk ambulatorium 8622

location_facility: Durban International Clinical Research Site (WWH)

location_facility: Infectious Diseases Associates NW FL, PA

location_facility: Coventry and Warwickshire NHS partnership Trust

location_facility: Klinik fur Dermatologie, Venerologie, Allergologie

location_facility: Helsinki University Central Hospital, Div. of Infectious Diseases CRS

location_facility: Center for Infectious Diseases at the UFES

location_facility: The Ohio State University Medical Center

location_facility: University College London Medical School

location_facility: CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral)

location_facility: Hippokration University General Hospital of Athens

location_facility: EPIMED-Gesellschaft fur epidemiologische und klinische Forschung in der MedizinmbH

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: AIDS Research and Treatment Center of the Treasure Coast

location_facility: Durban International Clinical Research Site

location_facility: Hospital General de Agudos JM Ramos Mejia

location_facility: Belfast Health and Social Care Trust (RVH)

location_facility: The Research + Education Group - Portland

location_facility: Centre Hospitalier - H�pital Gustave Dron

location_facility: Research Institute for Health Sciences (RIHES)

location_facility: Newland Immunology Center of Excellence (NICE)

location_facility: Hospital Escola Sao Francisco de Assis - UFRJ

location_facility: Otto-Wagner-Spital SMZ /Baumgartner Hoehe

lead_sponsor_type: academique


title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

lead_sponsor: Bayer

ReferenceCitation: Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.

ReferenceCitation: Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684.

ReferenceCitation: Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Jansa P, Kim NH, Mayer E, Pulido T, Wang C, Colorado P, Fritsch A, Meier C, Nikkho S, Hoeper MM. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):372-80. doi: 10.1016/S2213-2600(16)30022-4. Epub 2016 Apr 8.

ReferenceCitation: Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.

ReferenceCitation: Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2. Review.

ReferenceCitation: Kim DY, Kim HJ, Han KH, Han SY, Heo J, Woo HY, Um SH, Kim YH, Kweon YO, Lim HY, Yoon JH, Lee WS, Lee BS, Lee HC, Ryoo BY, Yoon SK. Real-Life Experience of Sorafenib Treatment for Hepatocellular Carcinoma in Korea: From GIDEON Data. Cancer Res Treat. 2016 Oct;48(4):1243-1252. Epub 2016 Feb 24.

ReferenceCitation: Kudo M, Ikeda M, Takayama T, Numata K, Izumi N, Furuse J, Okusaka T, Kadoya M, Yamashita S, Ito Y, Kokudo N. Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON. J Gastroenterol. 2016 Dec;51(12):1150-1160. Epub 2016 Apr 22.

ReferenceCitation: Kim NH, D'Armini AM, Grimminger F, Grünig E, Hoeper MM, Jansa P, Mayer E, Neurohr C, Simonneau G, Torbicki A, Wang C, Fritsch A, Davie N, Ghofrani HA. Haemodynamic effects of riociguat in inoperable/recurrent chronic thromboembolic pulmonary hypertension. Heart. 2017 Apr;103(8):599-606. doi: 10.1136/heartjnl-2016-309621. Epub 2016 Dec 23.

ReferenceCitation: Saleh S, Becker C, Frey R, Mück W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Slovakia
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
Ireland
Czech Republic
Korea, Republic of
France
Netherlands

location_facility:
Vseobecna fakultni nemocnice
Hopital Antoine Beclere

summary: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).


title: A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome

summary: The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

ReferenceCitation: Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.

ReferenceCitation: Gibson CM, Levitan B, Gibson WJ, Yee MK, Murphy SA, Yuan Z, Chakrabarti AK, Lee M, Braunwald E. Fatal or Irreversible Bleeding and Ischemic Events With Rivaroxaban in Acute Coronary Syndrome. J Am Coll Cardiol. 2018 Jul 10;72(2):129-136. doi: 10.1016/j.jacc.2018.04.055.

ReferenceCitation: Cavender MA, Gibson CM, Braunwald E, Wiviott SD, Murphy SA, Toda Kato E, Plotnikov AN, Amuchástegui M, Oude Ophuis T, van Hessen M, Mega JL. The effect of rivaroxaban on myocardial infarction in the ATLAS ACS 2 - TIMI 51 trial. Eur Heart J Acute Cardiovasc Care. 2015 Oct;4(5):468-74. doi: 10.1177/2048872614554109. Epub 2014 Oct 15.

ReferenceCitation: Gibson CM, Chakrabarti AK, Mega J, Bode C, Bassand JP, Verheugt FW, Bhatt DL, Goto S, Cohen M, Mohanavelu S, Burton P, Stone G, Braunwald E; ATLAS-ACS 2 TIMI 51 Investigators. Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS 2 TIMI 51. J Am Coll Cardiol. 2013 Jul 23;62(4):286-90. doi: 10.1016/j.jacc.2013.03.041. Epub 2013 Apr 16.

ReferenceCitation: Mega JL, Braunwald E, Murphy SA, Plotnikov AN, Burton P, Kiss RG, Parkhomenko A, Tendera M, Widimsky P, Gibson CM. Rivaroxaban in patients stabilized after a ST-segment elevation myocardial infarction: results from the ATLAS ACS-2-TIMI-51 trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction-51). J Am Coll Cardiol. 2013 May 7;61(18):1853-9. doi: 10.1016/j.jacc.2013.01.066. Epub 2013 Mar 7.

ReferenceCitation: Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, Verheugt FW, Gibson CM; ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19. doi: 10.1056/NEJMoa1112277. Epub 2011 Nov 13.

ReferenceCitation: Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6. doi: 10.1016/j.ahj.2011.01.026.

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Croatia
Serbia
Spain
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Philippines
Romania
Poland
Portugal
Russian Federation
Australia
Argentina
Tunisia
India
Israel
Turkey
Mexico
Malaysia
Sweden
Slovakia
Egypt
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
Greece
Latvia
New Zealand
Czech Republic
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands
Morocco


title: A Randomised, Double-blind, Parallel-group Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke

lead_sponsor: H. Lundbeck A/S

ReferenceCitation: Albers GW, von Kummer R, Truelsen T, Jensen JK, Ravn GM, Grønning BA, Chabriat H, Chang KC, Davalos AE, Ford GA, Grotta J, Kaste M, Schwamm LH, Shuaib A; DIAS-3 Investigators. Safety and efficacy of desmoteplase given 3-9 h after ischaemic stroke in patients with occlusion or high-grade stenosis in major cerebral arteries (DIAS-3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Neurol. 2015 Jun;14(6):575-84. doi: 10.1016/S1474-4422(15)00047-2. Epub 2015 Apr 30.

location_country:
Poland
Taiwan
Hong Kong
Spain
Austria
Australia
Estonia
Netherlands
Thailand
Switzerland
Vietnam
Korea, Republic of
France
India
Singapore
Philippines
Germany

summary: The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.