Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology
ORHEO
Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study
2 other identifiers
observational
2,333
1 country
172
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
172 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
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 14, 2014
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedFebruary 28, 2024
July 1, 2015
1.9 years
May 14, 2014
February 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change and corrected Hemoglobin levels
Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.
6 months
Secondary Outcomes (5)
Observe evolution of the biological indicators
6 months
Study the profiles of treated patients
6 months
Assess the reasons for the prescriber's treatment regimens
6 months
Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics
6 months
Observation of the safety profiles of the Product (Epoetin Alfa)
6 months
Study Arms (1)
Patients with chemo-induced symptomatic anemia
Interventions
Eligibility Criteria
Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (172)
Unknown Facility
Agen, 47000, France
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Aix-en-Provence, 13100, France
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Aix-en-Provence, 13101, France
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Aix-en-Provence, 13616, France
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Ajaccio, 20176, France
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Albi, 81000, France
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Amboise, 37400, France
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Amilly, 45200, France
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Annecy, 74000, France
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Antibes, 6606, France
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Armentières, 59421, France
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Arras, 62000, France
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Arras, 62022, France
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Aulnay-sous-Bois, 93602, France
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Avignon, 84000, France
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Avignon, 84082, France
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Bayonne, 64100, France
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Beauvais, 60021, France
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Besançon, 25030, France
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Beuvry, 62660, France
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Béthune, 62400, France
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Béziers, 34500, France
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Blois, 41000, France
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Bois-Guillaume, 76230, France
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Bordeaux, 33000, France
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Bordeaux, 33076, France
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Bordeaux, 33300, France
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Boulogne-sur-Mer, 62200, France
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Brest, 29200, France
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Brest, 29609, France
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Bron, 69500, France
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Caen, 14000, France
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Caen, 14033, France
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Cannes, 6401, France
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Cannes, 6414, France
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Carcassonne, 11000, France
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Carcassonne, 11890, France
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Castelnau-le-Lez, 34170, France
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Challes-les-Eaux, 73190, France
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Chalon/saonne, 71321, France
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Chambéry, 73000, France
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Chambéry, 73011, France
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Cherbourg-octeville, 50100, France
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Clermont-Ferrand, 63011, France
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Colmar, 68000, France
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Colmar, 68024, France
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Compiègne, 60321, France
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Créteil, 94000, France
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Croix, 59963, France
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Désertines, 3630, France
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Dijon, 21079, France
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Draguignan, 83007, France
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Draguignan, 83300, France
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Dunkirk, 59240, France
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Évreux, 27025, France
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Feurs, 42110, France
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Foix, 9017, France
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Freyming-Merlebach, 57804, France
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Fréjus, 83600, France
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Fréjus, 83608, France
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Fryming Merle BACH, 57800, France
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Gap, 5000, France
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Gap, 5007, France
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Grasse, 6135, France
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Haguenau, 67500, France
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Hyères, 83056, France
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Hyères, 83400, France
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La Roche-sur-Yon, 85925, France
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La Rochelle, 17019, France
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La Seyne-sur-Mer, 83500, France
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La Tronche, 38700, France
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Le Blanc-Mesnil, 93150, France
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Le Mans, 72037, France
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Lille, 59000, France
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Lille, 59037, France
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Limoges, 87042, France
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Lyon, 69000, France
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Lyon, 69365, France
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Lyon, 69373, France
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Lyon, 69424, France
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Lyon, 69437, France
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Mareuil LES MAUX, 77100, France
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Marseille, 13004, France
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Marseille, 13005, France
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Marseille, 13006, France
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Marseille, 13008, France
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Marseille, 13009, France
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Marseille, 13012, France
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Marseille, 13015, France
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Marseille, 13285, France
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Marseille, 13385, France
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Marseille, 13915, France
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Mâcon, 71018, France
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Meaux, 77100, France
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Metz, 57038, France
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Metz, 57077, France
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Monaco, 98012, France
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Mont-de-Marsan, 40024, France
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Montargis, 45207, France
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Montauban, 82013, France
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Montbéliard, 25200, France
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Montbéliard, 25209, France
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Montfermeil, 93370, France
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Montpellier, 34090, France
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Montpellier, 34295, France
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Morlaix, 29600, France
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Moulins, 3006, France
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Mulhouse, 68051, France
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Mulhouse, 68067, France
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Mulhouse, 68070, France
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Nancy, 54100, France
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Nantes, 44093, France
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Nantes Saint Herblain, 44805, France
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Narbonne, 11100, France
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Nice, 6000, France
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Nice, 6189, France
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Nice, 6202, France
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Niort, 79021, France
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Nîmes, 30029, France
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Nîmes, 30900, France
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Nogent/Marne, 94130, France
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Orléans, 45067, France
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Paris, 75004, France
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Paris, 75007, France
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Paris, 75014, France
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Paris, 75018, France
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Paris, 75116, France
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Perpignan, 66046, France
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Pessac, 33604, France
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Pierre-Bénite, 69495, France
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Poitiers, 86021, France
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Pontoise, 95300, France
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Pringy, 74370, France
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Pringy, 74374, France
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Reims, 51100, France
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Rennes, 35033, France
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Rouen, 76000, France
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Rouen, 76044, France
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Rouen, 76100, France
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Saint-Cloud, 92210, France
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Saint-Gaudens, 31800, France
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Saint-Germain-en-Laye, 78015, France
Unknown Facility
Saint-Germain-en-Laye, 78100, France
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Saint-Herblain, 44805, France
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Saint-Priest-en-Jarez, 42227, France
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Saint-Quentin, 02321, France
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Sainte-Feyre, 23000, France
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Sélestat, 67604, France
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Strasbourg, 67000, France
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Strasbourg, 67065, France
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Strasbourg, 67091, France
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Strasbourg, 67098, France
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Strasbourg, 67100, France
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Talence, 33401, France
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Tarbes, 65000, France
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Thionville, 57100, France
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Thonon-les-Bains, 74203, France
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Toulon, 83041, France
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Toulon, 83056, France
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Toulon, 83100, France
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Toulouse, 31059, France
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Toulouse, 31076, France
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Tours, 37044, France
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Tremblay-en-France, 93290, France
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Troyes, 10003, France
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Valence, 26953, France
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Vandœuvre-lès-Nancy, 54511, France
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Versailles, 78000, France
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Vénissieux, 69200, France
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Vichy, 3201, France
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Villefranche/saone, 69655, France
Unknown Facility
Villeneuve-sur-Lot, 47307, France
Related Publications (1)
Michallet M, Luporsi E, Soubeyran P, Amar NA, Boulanger V, Carreiro M, Dourthe LM, Labourey JL, Lepille D, Maloisel F, Mouysset JL, Nahon S, Narciso B, Nouyrigat P, Radji R, Sakek N, Albrand H; ORHEO study group. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study. BMC Cancer. 2014 Jul 10;14:503. doi: 10.1186/1471-2407-14-503.
PMID: 25011615DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2014
First Posted
May 16, 2014
Study Start
September 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
February 28, 2024
Record last verified: 2015-07