Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
SAVE-ONCO
A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
2 other identifiers
interventional
3,212
44 countries
381
Brief Summary
The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2008
381 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedFirst Posted
Study publicly available on registry
June 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJanuary 23, 2013
January 1, 2013
2.4 years
May 7, 2008
January 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death
VTE included any symptomatic Deep Vein Thrombosis \[DVT\] of lower or upper limbs and any non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after review of compression ultrasound or venography for DVT, ventilation/perfusion lung scan, pulmonary angiogram or spiral computer tomography lung scan for PE. VTE-related death included fatal PE and unexplained deaths without confirmatory autopsy. Any sudden death could be classified as fatal PE by the CIAC unless diagnostic test results strongly indicated an alternative diagnosis".
From randomization up to 3 days after last study drug injection
Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function)
Participants alive and not having experienced VTE were right censored at last study drug injection plus 3 days. In order to correct for competing risks (Deaths other than VTE-related death), a model of cause-specific hazards was used to estimate the Cumulative incidence Function with Prentice non-parametric estimator.
From randomization up to 3 days after last study drug injection
Secondary Outcomes (3)
Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
From randomization up to 3 days after last study drug injection
Percentage of Participants Who Experienced Clinically Relevant Bleedings
From first study drug injection up to 3 days after last study drug injection
Overall survival [OS]
From randomization up to 1 year after randomization or 7 months following randomization of the last participant, whichever came first
Other Outcomes (2)
Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]
From first study drug injection up to 3 days after last study drug injection
Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]
From first study drug injection up to 3 days after last study drug injection
Study Arms (2)
Semuloparin
EXPERIMENTALSemuloparin sodium 20 mg once daily until change in chemotherapy regimen
Placebo
PLACEBO COMPARATORPlacebo (for semuloparin) once daily until change in chemotherapy regimen
Interventions
0.4 mL solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
0.4 mL solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component Subcutaneous injection
Eligibility Criteria
You may qualify if:
- Cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy
You may not qualify if:
- Required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic;
- High risk of bleeding;
- Severe renal impairment (estimated creatinine clearance \<30 mL/min);
- ECOG (Eastern Cooperative Oncology Group) performance status 3 \& 4;
- Major surgery within 4 weeks before randomization;
- Known hypersensitivity to unfractionated heparin \[UFH\] or low molecular weight heparin \[LMWH\].
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (411)
Investigational Site Number 840006
Birmingham, Alabama, 35211, United States
Investigational Site Number 840007
Casa Grande, Arizona, 85222, United States
Investigational Site Number 840060
Tucson, Arizona, 85704, United States
Investigational Site Number 840050
Fountain Valley, California, 92708, United States
Investigational Site Number 840072
Fullerton, California, 92835, United States
Investigational Site Number 840037
Indian Wells, California, 92210, United States
Investigational Site Number 840069
La Verne, California, 91750, United States
Investigational Site Number 840009
Long Beach, California, 90806, United States
Investigational Site Number 840001
Oceanside, California, 92056, United States
Investigational Site Number 840011
Rancho Mirage, California, 92270, United States
Investigational Site Number 840029
West Covina, California, 91790, United States
Investigational Site Number 840005
Norwich, Connecticut, 06360, United States
Investigational Site Number 840064
Torrington, Connecticut, 06790, United States
Investigational Site Number 840038
Woodbridge, Connecticut, 06525, United States
Investigational Site Number 840052
Washington D.C., District of Columbia, 20010, United States
Investigational Site Number 840025
Washington D.C., District of Columbia, 20017, United States
Investigational Site Number 840074
Clearwater, Florida, 33756, United States
Investigational Site Number 840019
Jacksonville, Florida, 32207, United States
Investigational Site Number 840051
Rockledge, Florida, 32955, United States
Investigational Site Number 840073
Sarasota, Florida, 34239, United States
Investigational Site Number 840070
Roswell, Georgia, 30076, United States
Investigational Site Number 840016
Park Ridge, Illinois, 60068, United States
Investigational Site Number 840028
Quincy, Illinois, 62301, United States
Investigational Site Number 840008
Skokie, Illinois, 60077, United States
Investigational Site Number 840033
Goshen, Indiana, 46526, United States
Investigational Site Number 840010
Indianapolis, Indiana, 46237, United States
Investigational Site Number 840014
Louisville, Kentucky, 40202, United States
Investigational Site Number 840048
Mount Sterling, Kentucky, 40353, United States
Investigational Site Number 840047
Metairie, Louisiana, 70056, United States
Investigational Site Number 840032
Ruston, Louisiana, 71270, United States
Investigational Site Number 840042
Bethesda, Maryland, 20817, United States
Investigational Site Number 840066
Easton, Maryland, 21601, United States
Investigational Site Number 840059
Tupelo, Mississippi, 38801, United States
Investigational Site Number 840024
Rochester, New York, 14642, United States
Investigational Site Number 840031
Syracuse, New York, 13210, United States
Investigational Site Number 840020
Durham, North Carolina, 27710, United States
Investigational Site Number 840021
Durham, North Carolina, 27710, United States
Investigational Site Number 840026
High Point, North Carolina, 27262, United States
Investigational Site Number 840046
Bismarck, North Dakota, 58501, United States
Investigational Site Number 840003
Middletown, Ohio, 45042, United States
Investigational Site Number 840022
Sylvania, Ohio, 43560, United States
Investigational Site Number 840075
East Providence, Rhode Island, 02915, United States
Investigational Site Number 840067
Beaumont, Texas, 77701, United States
Investigational Site Number 840004
El Paso, Texas, 79915, United States
Investigational Site Number 840034
Houston, Texas, 77030, United States
Investigational Site Number 840035
Sugar Land, Texas, 77055, United States
Investigational Site Number 840063
Kennewick, Washington, 99336, United States
Investigational Site Number 840018
Tacoma, Washington, 98431, United States
Investigational Site Number 032006
Buenos Aires, 1425, Argentina
Investigational Site Number 032003
Capital Federal, 1264, Argentina
Investigational Site Number 032004
Rosario, S200PBJ, Argentina
Investigational Site Number 032007
San Miguel de Tucumán, T4000IAK, Argentina
Investigational Site Number 032005
San Miguel de Tucumán, T4000NIL, Argentina
Investigational Site Number 036004
Adelaide, 5000, Australia
Investigational Site Number 036002
Bedford Park, 5042, Australia
Investigational Site Number 036001
Box Hill, 3128, Australia
Investigational Site Number 036009
Lismore, 2480, Australia
Investigational Site Number 036007
Perth, 6000, Australia
Investigational Site Number 036006
Ringwood East, 3135, Australia
Investigational Site Number 036008
Westmead, 2145, Australia
Investigational Site Number 036003
Woodville, 5011, Australia
Investigational Site Number 036005
Woolloongabba, 4102, Australia
Investigational Site Number 040002
Graz, 8036, Austria
Investigational Site Number 040003
Vienna, 1090, Austria
Investigational Site Number 040004
Vienna, 1130, Austria
Investigational Site Number 112002
Homyel, 246012, Belarus
Investigational Site Number 112003
Minsk, 220013, Belarus
Investigational Site Number 112001
Minsk, 223040, Belarus
Investigational Site Number 112004
Vitebsk, 210603, Belarus
Investigational Site Number 056008
Bonheiden, 2820, Belgium
Investigational Site Number 056011
Brussels, 1020, Belgium
Investigational Site Number 056005
Ghent, 9000, Belgium
Investigational Site Number 056010
Haine-Saint-Paul, 7100, Belgium
Investigational Site Number 056006
Kortrijk, 8500, Belgium
Investigational Site Number 056009
Liège, 4000, Belgium
Investigational Site Number 056004
Merksem, 2170, Belgium
Investigational Site Number 056003
Ostend, Belgium
Investigational Site Number 056012
Ottignies, 1340, Belgium
Investigational Site Number 056002
Sint-Niklaas, Belgium
Investigational Site Number 076002
Belo Horizonte, 30150-221, Brazil
Investigational Site Number 076022
Curitiba, 80730 170, Brazil
Investigational Site Number 076015
Curitiba, 81520-060, Brazil
Investigational Site Number 076012
Florianópolis, 88015-240, Brazil
Investigational Site Number 076001
Fortaleza, 60336-550, Brazil
Investigational Site Number 076009
Goiânia, 74070-040, Brazil
Investigational Site Number 076007
Goiânia, 74605-070, Brazil
Investigational Site Number 076016
Goiânia, 74605-070, Brazil
Investigational Site Number 076024
Ijuí, 98700 000, Brazil
Investigational Site Number 076003
Joinville, 89202-000, Brazil
Investigational Site Number 076010
Londrina, 86050-190, Brazil
Investigational Site Number 076026
Passo Fundo, 99010-080, Brazil
Investigational Site Number 076027
Passo Fundo, 99010-260, Brazil
Investigational Site Number 076023
Porto Alegre, 90020-090, Brazil
Investigational Site Number 076020
Porto Alegre, 90430-090, Brazil
Investigational Site Number 076014
Salvador, 40050-410, Brazil
Investigational Site Number 076018
Salvador, 41825-010, Brazil
Investigational Site Number 076011
Santo André, 09090-780, Brazil
Investigational Site Number 076006
São José dos Campos, 12245-750, Brazil
Investigational Site Number 076008
São Paulo, 04039-901, Brazil
Investigational Site Number 076017
São Paulo, 04122 000, Brazil
Investigational Site Number 076004
Taguatinga, 72115-700, Brazil
Investigational Site Number 100001
Rousse, 7002, Bulgaria
Investigational Site Number 100003
Varna, 9010, Bulgaria
Investigational Site Number 124008
Greenfield Park, J4V 2H1, Canada
Investigational Site Number 124007
Kelowna, Canada
Investigational Site Number 124010
Moncton, E1C 8X3, Canada
Investigational Site Number 124003
Montreal, H3T 1E2, Canada
Investigational Site Number 124002
Ottawa, K1Y 4E9, Canada
Investigational Site Number 124009
Owen Sound, N4K 2J1, Canada
Investigational Site Number 124006
Rimouski, G5L 5T1, Canada
Investigational Site Number 124013
Saint John, E2L 4L2, Canada
Investigational Site Number 124001
Sherbrooke, J1H 5N4, Canada
Investigational Site Number 124012
Victoria, V8R 6V5, Canada
Investigational Site Number 124011
Weston, M9N 1N8, Canada
Investigational Site Number 152002
Temuco, 4810469, Chile
Investigational Site Number 156014
Beijing, 100029, China
Investigational Site Number 156008
Beijing, 100071, China
Investigational Site Number 156022
Beijing, 101149, China
Investigational Site Number 156031
Changchun, 130021, China
Investigational Site Number 156021
Chengdu, 610083, China
Investigational Site Number 156019
Chongqing, 400037, China
Investigational Site Number 156003
Dalian, 116011, China
Investigational Site Number 156025
Guangzhou, 510405, China
Investigational Site Number 156026
Hangzhou, 310016, China
Investigational Site Number 156030
Nanning, 530021, China
Investigational Site Number 156029
Qingdao, 266003, China
Investigational Site Number 156024
Shanghai, 200032, China
Investigational Site Number 156028
Shanghai, 200072, China
Investigational Site Number 156020
Shanghai, 200233, China
Investigational Site Number 156011
Shanghai, 200433, China
Investigational Site Number 156013
Shantou, 515041, China
Investigational Site Number 156012
Suzhou, 215004, China
Investigational Site Number 156004
Xi'an, 710032, China
Investigational Site Number 156009
Xi'an, 710038, China
Investigational Site Number 156027
Yinchuan, 750004, China
Investigational Site Number 170010
Bogotá, Colombia
Investigational Site Number 170005
Manizales, Colombia
Investigational Site Number 170002
Medellín, Colombia
Investigational Site Number 170006
Medellín, Colombia
Investigational Site Number 170007
Medellín, Colombia
Investigational Site Number 170008
Montería, Colombia
Investigational Site Number 170004
Pereira, Colombia
Investigational Site Number 191006
Pula, 52100, Croatia
Investigational Site Number 191005
Rijeka, 51000, Croatia
Investigational Site Number 191007
Varaždin, 42000, Croatia
Investigational Site Number 191003
Zadar, 23000, Croatia
Investigational Site Number 191008
Zagreb, 10000, Croatia
Investigational Site Number 191001
Zagreb, Croatia
Investigational Site Number 191004
Zagreb, Croatia
Investigational Site Number 203004
Hradec Králové, 50005, Czechia
Investigational Site Number 203008
Kolín, 28020, Czechia
Investigational Site Number 203007
Nová Ves pod Pleší, 26202, Czechia
Investigational Site Number 203003
Prague, 15006, Czechia
Investigational Site Number 208001
Herlev, 2730, Denmark
Investigational Site Number 233001
Tallinn, 10167, Estonia
Investigational Site Number 246001
Turku, FIN-20520, Finland
Investigational Site Number 250002
Antibes, 06606, France
Investigational Site Number 250010
Colmar, 68024, France
Investigational Site Number 250020
Gap, 5007, France
Investigational Site Number 250005
Lille, 59020, France
Investigational Site Number 250025
Lille, 59020, France
Investigational Site Number 250012
Lille, 59037, France
Investigational Site Number 250003
Lyon, 69003, France
Investigational Site Number 250001
Marseille, 13273, France
Investigational Site Number 250024
Montpellier, 34094, France
Investigational Site Number 250006
Paris, 75475, France
Investigational Site Number 250027
Paris, 75475, France
Investigational Site Number 250004
Paris, 75674, France
Investigational Site Number 250021
Reims, 51100, France
Investigational Site Number 250019
Rouen, 76031, France
Investigational Site Number 250017
Saint-Grégoire, 35570, France
Investigational Site Number 250014
Vandœuvre-lès-Nancy, 54500, France
Investigational Site Number 276012
Augsburg, 86150, Germany
Investigational Site Number 276025
Berlin, 10117, Germany
Investigational Site Number 276016
Berlin, 13125, Germany
Investigational Site Number 276002
Berlin, 13353, Germany
Investigational Site Number 276029
Berlin, 13585, Germany
Investigational Site Number 276004
Bochum, 44791, Germany
Investigational Site Number 276006
Cologne, 51109, Germany
Investigational Site Number 276014
Dresden, 01219, Germany
Investigational Site Number 276009
Dresden, 01307, Germany
Investigational Site Number 276030
Essen, 45136, Germany
Investigational Site Number 276005
Frankfurt am Main, 65929, Germany
Investigational Site Number 276032
Gauting, 82131, Germany
Investigational Site Number 276034
Halle, 06120, Germany
Investigational Site Number 276038
Halle, 06120, Germany
Investigational Site Number 276037
Hamburg, 22457, Germany
Investigational Site Number 276007
Hanover, 30625, Germany
Investigational Site Number 276020
Leer, 26789, Germany
Investigational Site Number 276010
Leipzig, 04207, Germany
Investigational Site Number 276017
Magdeburg, 39104, Germany
Investigational Site Number 276011
Mannheim, 68167, Germany
Investigational Site Number 276003
Minden, 32427, Germany
Investigational Site Number 276021
München, 81377, Germany
Investigational Site Number 276019
München, 81545, Germany
Investigational Site Number 276015
München, 81737, Germany
Investigational Site Number 276013
Neumünster, 24634, Germany
Investigational Site Number 276022
Oldenburg, 26121, Germany
Investigational Site Number 276035
Paderborn, 33098, Germany
Investigational Site Number 276031
Passau, 94032, Germany
Investigational Site Number 276023
Rosenheim, 83022, Germany
Investigational Site Number 276008
Singen, 78224, Germany
Investigational Site Number 276024
Westerstede, 26655, Germany
Investigational Site Number 300004
Athens, 11527, Greece
Investigational Site Number 300003
Heraklion, 71110, Greece
Investigational Site Number 300002
Thessaloniki, 54629, Greece
Investigational Site Number 344001
Hong Kong, Hong Kong
Investigational Site Number 348005
Budapest, 1076, Hungary
Investigational Site Number 348006
Budapest, 1106, Hungary
Investigational Site Number 348009
Budapest, 1121, Hungary
Investigational Site Number 348004
Budapest, 1125, Hungary
Investigational Site Number 348010
Farkasgyepű, 8582, Hungary
Investigational Site Number 348001
Gyula, 5700, Hungary
Investigational Site Number 348012
Mátraháza, 3233, Hungary
Investigational Site Number 348003
Sopron, 9700, Hungary
Investigational Site Number 348008
Szikszó, 3800, Hungary
Investigational Site Number 348011
Szolnok, 5000, Hungary
Investigational Site Number 348007
Zalaegerszeg, 8900, Hungary
Investigational Site Number 356006
Bangalore, 560029, India
Investigational Site Number 356008
Bangalore, India
Investigational Site Number 356009
Bhopal, 462 001 (M.P), India
Investigational Site Number 356018
Chennai, India
Investigational Site Number 356020
Chennai, India
Investigational Site Number 356019
Coimbatore, 641037, India
Investigational Site Number 356015
Hyderabad, 500004, India
Investigational Site Number 356025
Hyderabad, 500004, India
Investigational Site Number 356011
Jaipur, India
Investigational Site Number 356014
Kochi, India
Investigational Site Number 356003
Kolkata, 700026, India
Investigational Site Number 356013
Kolkata, India
Investigational Site Number 356017
Kolkata, India
Investigational Site Number 356005
Madurai, India
Investigational Site Number 356016
Miraj, India
Investigational Site Number 356001
Mumbai, 400026, India
Investigational Site Number 356023
Nagpur, India
Investigational Site Number 356002
New Delhi, 110060, India
Investigational Site Number 356004
Pune, 411001, India
Investigational Site Number 356024
Pune, 411004, India
Investigational Site Number 356012
Visakhapatnam, 530002, India
Investigational Site Number 360002
Bandung, 40161, Indonesia
Investigational Site Number 360001
Denpasar, 80114, Indonesia
Investigational Site Number 360004
Medan, 20136, Indonesia
Investigational Site Number 372003
Dublin, D24, Ireland
Investigational Site Number 372002
Dublin, D9, Ireland
Investigational Site Number 372004
Dublin, Ireland
Investigational Site Number 376003
Jerusalem, 91031, Israel
Investigational Site Number 376004
Kfar Saba, 44281, Israel
Investigational Site Number 376001
Nahariya, 22100, Israel
Investigational Site Number 376006
Petah Tikva, 49100, Israel
Investigational Site Number 376007
Tzrifin, 70300, Israel
Investigational Site Number 380005
Castellanza, 21053, Italy
Investigational Site Number 380014
Cattolica, 47861, Italy
Investigational Site Number 380007
Cesena, 47023, Italy
Investigational Site Number 380015
Cremona, 26100, Italy
Investigational Site Number 380009
Faenza, 48018, Italy
Investigational Site Number 380012
Lecce, 73100, Italy
Investigational Site Number 380006
Lugo, 48022, Italy
Investigational Site Number 380001
Meldola, 47014, Italy
Investigational Site Number 380011
Parma, 43100, Italy
Investigational Site Number 380020
Perugia, 06128, Italy
Investigational Site Number 380013
Ravenna, 48121, Italy
Investigational Site Number 380016
Rimini, 47900, Italy
Investigational Site Number 380004
Sondrio, 23100, Italy
Investigational Site Number 380010
Sora, 03039, Italy
Investigational Site Number 380008
Taormina, 98039, Italy
Investigational Site Number 380019
Terni, 05100, Italy
Investigational Site Number 380003
Treviglio, 24047, Italy
Investigational Site Number 380017
Udine, 33100, Italy
Investigational Site Number 428002
Liepāja, 3401, Latvia
Investigational Site Number 428003
Riga, 1079, Latvia
Investigational Site Number 428001
Riga, LV-1002, Latvia
Investigational Site Number 440001
Kaunas, 06080, Lithuania
Investigational Site Number 440002
Vilnius, LT-08661, Lithuania
Investigational Site Number 458004
George Town, 11900, Malaysia
Investigational Site Number 458005
George Town, 11900, Malaysia
Investigational Site Number 458001
Kota Kinabalu, 88996, Malaysia
Investigational Site Number 458003
Kuala Lumpur, 50603, Malaysia
Investigational Site Number 484002
Acapulco, 39670, Mexico
Investigational Site Number 484006
Aguascalientes, 20230, Mexico
Investigational Site Number 484007
Durango, 34260, Mexico
Investigational Site Number 484008
Mérida, 97000, Mexico
Investigational Site Number 484012
Puebla City, 72550, Mexico
Investigational Site Number 484003
Toluca, 50120, Mexico
Investigational Site Number 484010
Xalapa, 91130, Mexico
Investigational Site Number 528004
Groningen, 9728 NT, Netherlands
Investigational Site Number 528005
Helmond, 5707 HA, Netherlands
Investigational Site Number 528001
Hoofddorp, 2134 TM, Netherlands
Investigational Site Number 528003
Rotterdam, 3083 AN, Netherlands
Investigational Site Number 528006
The Hague, 2545 CH, Netherlands
Investigational Site Number 578001
Oslo, 0407, Norway
Investigational Site Number 604012
Arequipa, Peru
Investigational Site Number 604004
Callao, CALLAO 02, Peru
Investigational Site Number 604011
Callao, CALLAO 02, Peru
Investigational Site Number 604001
Cercado, Peru
Investigational Site Number 604002
Chiclayo, Peru
Investigational Site Number 604008
Lima, LIMA 11, Peru
Investigational Site Number 604007
Lima, LIMA 13, Peru
Investigational Site Number 604009
Lima, LIMA 13, Peru
Investigational Site Number 604005
Lima, LIMA 34, Peru
Investigational Site Number 604006
Lima, LIMA 34, Peru
Investigational Site Number 604010
Lima, LIMA 34, Peru
Investigational Site Number 604003
Lima, Peru
Investigational Site Number 616009
Bialystok, 15-069, Poland
Investigational Site Number 616008
Bielsko-Biala, 43-300, Poland
Investigational Site Number 616006
Gliwice, 44-101, Poland
Investigational Site Number 616004
Krakow, 31-826, Poland
Investigational Site Number 616003
Lubin, 59-300, Poland
Investigational Site Number 616019
Olsztyn, 10-228, Poland
Investigational Site Number 616021
Otwock, 05-400, Poland
Investigational Site Number 616010
Poznan, 60-569, Poland
Investigational Site Number 616001
Prabuty, 82-550, Poland
Investigational Site Number 616014
Rybnik, 44-200, Poland
Investigational Site Number 616005
Rzeszów, 35-021, Poland
Investigational Site Number 616013
Torun, 87-100, Poland
Investigational Site Number 616018
Warsaw, 00-416, Poland
Investigational Site Number 616002
Warsaw, 02-097, Poland
Investigational Site Number 616015
Wroclaw, 53-439, Poland
Investigational Site Number 620003
Aveiro, 3814-501, Portugal
Investigational Site Number 620009
Guimarães, 4835-044, Portugal
Investigational Site Number 620004
Lisbon, 1070, Portugal
Investigational Site Number 620008
Matosinhos Municipality, 4454-509, Portugal
Investigational Site Number 620007
Porto, 4200-072, Portugal
Investigational Site Number 620002
Setúbal, 2910-446, Portugal
Investigational Site Number 642004
Brasov, 500117, Romania
Investigational Site Number 642002
Bucharest, 022328, Romania
Investigational Site Number 642001
Cluj-Napoca, 400015, Romania
Investigational Site Number 642006
Cluj-Napoca, 400015, Romania
Investigational Site Number 642010
Iași, 700106, Romania
Investigational Site Number 642003
Suceava, 720237, Romania
Investigational Site Number 642008
Timișoara, 300041, Romania
Investigational Site Number 643024
Berdsk, 633190, Russia
Investigational Site Number 643006
Chelyabinsk, 454087, Russia
Investigational Site Number 643001
Kazan', 420111, Russia
Investigational Site Number 643004
Krasnoyarsk, 660113, Russia
Investigational Site Number 643010
Obninsk, 249036, Russia
Investigational Site Number 643005
Omsk, 644013, Russia
Investigational Site Number 643022
Pyatigorsk, 357502, Russia
Investigational Site Number 643023
Rostov-on-Don, 344037, Russia
Investigational Site Number 643009
Saint Petersburg, 196084, Russia
Investigational Site Number 643014
Saint Petersburg, 197089, Russia
Investigational Site Number 643015
Saint Petersburg, 197089, Russia
Investigational Site Number 643011
Saint Petersburg, 197758, Russia
Investigational Site Number 643020
Saratov, 410004, Russia
Investigational Site Number 643019
Smolensk, 214000, Russia
Investigational Site Number 643021
Sochi, 354057, Russia
Investigational Site Number 643008
Tomsk, 634050, Russia
Investigational Site Number 643016
Tula, 300053, Russia
Investigational Site Number 643018
Tyumen, 625023, Russia
Investigational Site Number 643012
Ufa, 450054, Russia
Investigational Site Number 643007
Vladivostok, 690105, Russia
Investigational Site Number 643017
Voronezh, 394000, Russia
Investigational Site Number 643003
Yaroslavl, 150040, Russia
Investigational Site Number 688002
Belgrade, 11000, Serbia
Investigational Site Number 688004
Belgrade, 11080, Serbia
Investigational Site Number 688007
Kragujevac, 34000, Serbia
Investigational Site Number 688005
Niš, 18000, Serbia
Investigational Site Number 703003
Trnava, 91775, Slovakia
Investigational Site Number 705003
Golnik, 4204, Slovenia
Investigational Site Number 705002
Maribor, 2000, Slovenia
Investigational Site Number 710003
Durban, 400, South Africa
Investigational Site Number 710002
Durban, 4091, South Africa
Investigational Site Number 410008
Daegu, 700-712, South Korea
Investigational Site Number 410007
Seoul, 110-744, South Korea
Investigational Site Number 410001
Seoul, 120-752, South Korea
Investigational Site Number 410002
Seoul, 120-752, South Korea
Investigational Site Number 410006
Seoul, 135-710, South Korea
Investigational Site Number 410005
Seoul, 136-705, South Korea
Investigational Site Number 410003
Seoul, 137-701, South Korea
Investigational Site Number 410009
Seoul, 152-703, South Korea
Investigational Site Number 410004
Suwon, 442-060, South Korea
Investigational Site Number 724008
Barakaldo, 48903, Spain
Investigational Site Number 724010
Barakaldo, 48903, Spain
Investigational Site Number 724004
Barcelona, 08036, Spain
Investigational Site Number 724006
Islas Baleares, 07014, Spain
Investigational Site Number 724011
Lleida, 25198, Spain
Investigational Site Number 724001
Madrid, 28034, Spain
Investigational Site Number 724007
Madrid, 28034, Spain
Investigational Site Number 724013
Madrid, 28035, Spain
Investigational Site Number 724012
Madrid, 28040, Spain
Investigational Site Number 724005
Ourense, 32005, Spain
Investigational Site Number 724003
Port de Sagunt, 46520, Spain
Investigational Site Number 724002
Valencia, 46017, Spain
Investigational Site Number 752003
Gothenburg, 416 85, Sweden
Investigational Site Number 752005
Mora, 792 85, Sweden
Investigational Site Number 752002
Uppsala, 751 85, Sweden
Investigational Site Number 752001
Vaxjo, 351 85, Sweden
Investigational Site Number 756006
Aarau, 5001, Switzerland
Investigational Site Number 756004
Winterthur, 8401, Switzerland
Investigational Site Number 158004
Changhua, 500, Taiwan
Investigational Site Number 804008
Cherkasy, 18009, Ukraine
Investigational Site Number 804009
Chernivtsi, 58001, Ukraine
Investigational Site Number 804002
Dnipropetrovsk, 49102, Ukraine
Investigational Site Number 804006
Donetsk, 83092, Ukraine
Investigational Site Number 804005
Kryvyi Rih, 50048, Ukraine
Investigational Site Number 804001
Lutsk, 43018, Ukraine
Investigational Site Number 804010
Lviv, 79031, Ukraine
Investigational Site Number 804011
Sumy, 40005, Ukraine
Investigational Site Number 804004
Ternopil, 46023, Ukraine
Investigational Site Number 826016
Bangor, LL57 2PW, United Kingdom
Investigational Site Number 826010
Brighton, BN2 5BE, United Kingdom
Investigational Site Number 826015
Coventry, CV2 2DX, United Kingdom
Investigational Site Number 826013
Dundee, DD1 9SY, United Kingdom
Investigational Site Number 826007
Hull, HU8 9HE, United Kingdom
Investigational Site Number 826002
Lincoln, LN2 5QY, United Kingdom
Investigational Site Number 826017
Lincoln, LN2 5QY, United Kingdom
Investigational Site Number 826005
Manchester, M20 4BX, United Kingdom
Investigational Site Number 826014
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Investigational Site Number 826004
Norwich, NR4 7UY, United Kingdom
Investigational Site Number 826009
Peterborough, PE3 6DA, United Kingdom
Investigational Site Number 826011
Portsmouth, PO3 6AD, United Kingdom
Investigational Site Number 826001
Shrewsbury, SY3 8XQ, United Kingdom
Related Publications (2)
Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.
PMID: 22335737RESULTRutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
PMID: 33337539DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alexander Turpie, MD
HHS-General Hospital, Hamilton, Canada
- PRINCIPAL INVESTIGATOR
Giancarlo Agnelli, MD
University Of Perugia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2008
First Posted
June 10, 2008
Study Start
June 1, 2008
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
January 23, 2013
Record last verified: 2013-01