- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02140736
Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology (ORHEO)
February 26, 2024 updated by: Hospira, now a wholly owned subsidiary of Pfizer
Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study
The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with adults patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anemia and being treated with biosimilar of epoetin to correct haemoglobin levels.
Study Type
Observational
Enrollment (Actual)
2333
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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AULNAY SOUS BOIS Cedex, France, 93602
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Agen, France, 47000
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Aix En Provence, France, 13616
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Aix En Provence, France, 13100
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Aix En Provence, France, 13101
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Aix En Provence Cedex, France, 13616
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Ajaccio Cedex, France, 20176
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Albi, France, 81000
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Amboise, France, 37400
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Amilly, France, 45200
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Annecy, France, 74000
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Antibes, France, 6606
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Armentieres, France, 59421
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Arras, France, 62000
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Arras Cedex, France, 62022
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Avignon, France, 84000
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Avignon Cedex 2, France, 84082
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Bayonne, France, 64100
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Beauvais, France, 60021
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Besancon, France, 25030
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Besancon Cedex, France, 25030
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Bethune, France, 62400
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Beuvry, France, 62660
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Beziers, France, 34500
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Blois, France, 41000
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Bois-guillaume, France, 76230
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Bordeaux, France, 33000
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Bordeaux, France, 33300
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Bordeaux Cedex, France, 33076
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Boulogne Sur Mer, France, 62200
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Brest, France, 29609
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Brest, France, 29200
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Brest Cedex, France, 29609
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Bron, France, 69500
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Caen, France, 14000
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Caen, France, 14033
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Cannes, France, 6401
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Cannes, France, 6414
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Carcassonne, France, 11000
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Carcassonne Cedex 9, France, 11890
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Castelnau Le Lez, France, 34170
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Challes Les Eaux, France, 73190
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Chalon/saonne, France, 71321
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Chambery, France, 73000
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Chambery, France, 73011
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Chambery Cedex, France, 73011
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Cherbourg-octeville, France, 50100
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Clermont Ferrand Cedex 1, France, 63011
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Colmar, France, 68024
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Colmar, France, 68000
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Colmar Cedex, France, 68024
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Compiegne, France, 60321
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Creteil, France, 94000
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Croix, France, 59963
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Croix Cedex, France, 59963
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Desertines, France, 3630
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Dijon Cedex, France, 21079
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Draguignan, France, 83007
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Draguignan Cedex, France, 83007
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Draguignan Cedex, France, 83300
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Dunkerque, France, 59240
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Evreux, France, 27025
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Feurs, France, 42110
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Foix Cedex, France, 9017
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Frejus, France, 83608
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Frejus, France, 83600
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Frejus Cedex, France, 83608
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Freyming Merlebach, France, 57804
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Fryming Merle BACH, France, 57800
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GAP, France, 5000
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Gap Cedex, France, 5007
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Grasse, France, 6135
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Haguenau, France, 67500
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Hyeres, France, 83400
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Hyeres, France, 83056
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La Roche Sur Yon Cedex 9, France, 85925
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La Rochelle Cedex 1, France, 17019
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La Seyne Sur Mer, France, 83500
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La Tronche, France, 38700
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Le Blanc Mesnil, France, 93150
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Le Mans Cedex 9, France, 72037
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Lille, France, 59037
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Lille, France, 59000
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Lille Cedex, France, 59000
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Limoges Cedex, France, 87042
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Lyon, France, 69437
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Lyon, France, 69000
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Lyon, France, 69424
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Lyon Cedex 07, France, 69365
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Lyon Cedex 8, France, 69373
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Macon Cedex, France, 71018
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Mareuil LES MAUX, France, 77100
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Marseille, France, 13009
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Marseille, France, 13385
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Marseille, France, 13006
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Marseille, France, 13005
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Marseille, France, 13008
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Marseille, France, 13012
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Marseille, France, 13015
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Marseille, France, 13004
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Marseille Cedex 08, France, 13285
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Marseille Cedex 20, France, 13915
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Meaux, France, 77100
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Metz Cedex 01, France, 57038
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Metz Cedex 3, France, 57077
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Monaco, France, 98012
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Mont de Marsan, France, 40024
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Montargis Cedex, France, 45207
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Montauban, France, 82013
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Montbeliard, France, 25209
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Montbeliard, France, 25200
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Montfermeil, France, 93370
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Montpellier, France, 34295
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Montpellier, France, 34090
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Montpellier Cedex 5, France, 34295
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Morlaix, France, 29600
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Moulins, France, 3006
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Mulhouse, France, 68070
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Mulhouse, France, 68051
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Mulhouse Cedex, France, 68070
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Mulhouse Cedex, France, 68067
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Nancy, France, 54100
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Nantes, France, 44093
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Nantes Saint Herblain, France, 44805
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Narbonne, France, 11100
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Nice, France, 6000
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Nice, France, 6189
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Nice Cedex 03, France, 6202
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Nice Cedex 2, France, 6189
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Nimes, France, 30900
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Niort, France, 79021
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Nogent/Marne, France, 94130
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Nîmes Cedex, France, 30029
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Orleans, France, 45067
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Paris, France, 75018
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Paris, France, 75014
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Paris, France, 75007
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Paris, France, 75004
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Paris, France, 75116
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Perpignan Cedex, France, 66046
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Pessac, France, 33604
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Pierre Benite Cedex, France, 69495
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Poitiers, France, 86021
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Pontoise, France, 95300
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Pringy, France, 74370
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Pringy Cedex, France, 74374
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Reims, France, 51100
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Rennes Cedex 9, France, 35033
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Rouen, France, 76000
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Rouen, France, 76100
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Rouen, France, 76044
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Saint Cloud, France, 92210
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Saint Gaudens, France, 31800
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Saint Germain En Laye, France, 78015
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Saint Quentin, France, 02321
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Sainte Feyre, France, 23000
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Selestat, France, 67604
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St Cloud, France, 92210
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St Germain, France, 78100
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St Germain En Laye, France, 78100
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St HERBLAIN CEDEX, France, 44805
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St Priest En Jarez Cedex, France, 42227
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Strasbourg, France, 67098
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Strasbourg, France, 67100
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Strasbourg, France, 67000
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Strasbourg Cedex, France, 67091
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Strasbourg Cedex, France, 67065
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Strasbourg Cedex 2, France, 67098
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Talence, France, 33401
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Talence Cedex, France, 33401
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Tarbes, France, 65000
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Thionville, France, 57100
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Thonon-les-bains, France, 74203
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Toulon, France, 83056
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Toulon, France, 83100
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Toulon Cedex 9, France, 83041
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Toulouse, France, 31076
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Toulouse Cedex 9, France, 31059
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Tours Cedex 9, France, 37044
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Tremblay En France, France, 93290
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Troyes, France, 10003
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Valence Cedex, France, 26953
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Vandoeuvre Les Nancy, France, 54511
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Venissieux, France, 69200
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Versailles, France, 78000
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Vichy, France, 3201
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Villefranche/saone, France, 69655
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Villeneuve Sur Lot, France, 47307
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
Description
Inclusion Criteria:
- Patients of more than 18 years of age
- Patients presenting with anemia following chemotherapy
Patients suffer from solid tumours, malignant hemopathies, lymphomas or myelomas and presenting with anemia following chemotherapy
-- The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle)
- Patients eligible for epoetin alfa biosimilar treatment
Exclusion Criteria:
- Patients are not receiving chemotherapy
- Patients already included in an epoetin zeta trial
- Patients presenting with a contraindication to epoetin zeta
- Patients presenting with hypersensitivity to the active principle or any of the excipients
- Patient with erythroblastopenia or acquired pure red cell aplasia (APRCA)
- Patient with uncontrollable arterial hypertension
- Patients who cannot receive adequate prophylaxis by antithrombotic agents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients with chemo-induced symptomatic anemia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change and corrected Hemoglobin levels
Time Frame: 6 months
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Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observe evolution of the biological indicators
Time Frame: 6 months
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Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation
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6 months
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Study the profiles of treated patients
Time Frame: 6 months
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6 months
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Assess the reasons for the prescriber's treatment regimens
Time Frame: 6 months
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6 months
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Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics
Time Frame: 6 months
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6 months
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Observation of the safety profiles of the Product (Epoetin Alfa)
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
May 14, 2014
First Submitted That Met QC Criteria
May 14, 2014
First Posted (Estimated)
May 16, 2014
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1_09.04.2009
- 09.214 (Other Identifier: CCTIRS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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